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Longer titles found: Abbreviated New Drug Application (view)

searching for New Drug Application 171 found (348 total)

alternate case: new Drug Application

Anticonvulsant (5,294 words) [view diff] exact match in snippet view article find links to article

2019. "New Drug Application (NDA) 017533". Drugs@FDA. U.S. Food and Drug Administration (FDA). Retrieved 21 November 2019. "New Drug Application (NDA)
Roluperidone (614 words) [view diff] exact match in snippet view article find links to article
performance measurements." However, in August 2022 Minerva submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the approval
Cefsulodin (227 words) [view diff] case mismatch in snippet view article find links to article
Takeda Pharmaceutical Company in 1977. TAP Pharmaceuticals had a new drug application on file with FDA for cefsulodin under the brand name Cefonomil as
Peginesatide (572 words) [view diff] exact match in snippet view article find links to article
that Takeda will work with the FDA to withdraw the peginesatide New Drug Application. Two randomized controlled trials published in 2013 found that the
Hydrocodone/ibuprofen (1,662 words) [view diff] case mismatch in snippet view article find links to article
a new drug. Knoll filed an investigational new drug application on 30 December 1986. A new drug application was later filed by Knoll on 25 April 1996,
Garenoxacin (317 words) [view diff] exact match in snippet view article find links to article
the United States Food and Drug Administration had accepted the New Drug Application (NDA) for garenoxacin, and had been granted a 10-month review. As
Spectrum Pharmaceuticals (1,093 words) [view diff] exact match in snippet view article find links to article
FDA acceptance of the New Drug Application (NDA) submitted for Poziotinib Dec 6, 2021 Spectrum submitted the New Drug Application (NDA) for Poziotinib
Nancy Lord (386 words) [view diff] case mismatch in snippet view article find links to article
employed by Abbott Laboratories, where she authored the successful new drug application for benzodiazepine hypnotic ("ProSom"). After leaving Abbott, Lord
Prulifloxacin (1,614 words) [view diff] exact match in snippet view article find links to article
fluoroquinolone class undergoing clinical trials prior to a possible NDA (New Drug Application) submission to the U.S. Food and Drug Administration (FDA). It is
Cefiderocol (1,937 words) [view diff] exact match in snippet view article find links to article
2020, cefiderocol (Fetroja) received FDA approval as supplemental New Drug Application (sNDA) for treatment of hospital-acquired bacterial pneumonia (HABP)
Domperidone (5,490 words) [view diff] case mismatch in snippet view article find links to article
problems under an expanded access individual-patient investigational new drug application. An analogue of domperidone called deudomperidone is also currently
Rubitecan (403 words) [view diff] exact match in snippet view article find links to article
submission of New Drug Application (NDA) for Orathecin as an oral treatment for pancreatic cancer". Drugs.com. Retrieved 2008-03-25. "SuperGen's New Drug Application
Calcimimetic (319 words) [view diff] case mismatch in snippet view article find links to article
On August 25, 2015 Amgen Inc. announced that it had submitted a new drug application with the United States Food and Drug Administration for a new calcimimetic
Umbralisib (1,275 words) [view diff] exact match in snippet view article find links to article
the pending Biologics License Application (BLA) and supplemental New Drug Application (sNDA) for the treatment of chronic lymphocytic leukemia (CLL) and
FDA citizen petition (591 words) [view diff] exact match in snippet view article find links to article
companies may also present arguments to the FDA that the Abbreviated New Drug Application (ANDA) should not be accepted by filing a "citizen petition" with
Peramivir (1,046 words) [view diff] exact match in snippet view article find links to article
under the current $234.8 million contract to enable completion of a New Drug Application filing for intravenous (IV) peramivir. According to a research report
Duvelisib (1,345 words) [view diff] exact match in snippet view article find links to article
same PI3 kinase inhibitor class. In April 2018, Verastem filed a New Drug Application (NDA) for duvelisib for the treatment of relapsed or refractory chronic
Motexafin gadolinium (142 words) [view diff] exact match in snippet view article find links to article
chemotherapeutic agent in the treatment of brain metastases. On May 9, 2006, a New Drug Application was submitted to the United States Food and Drug Administration (FDA)
Carfilzomib (1,730 words) [view diff] case mismatch in snippet view article find links to article
of its new drug application for carfilzomib. In December 2011, the FDA granted Onyx standard review designation, for its new drug application submission
Taliglucerase alfa (452 words) [view diff] exact match in snippet view article find links to article
The U.S. FDA New Drug Application (NDA) was granted approval in May 2012, for use in adults. The U.S. FDA Supplemental New Drug Application (sNDA) for pediatric
Celiprolol (229 words) [view diff] case mismatch in snippet view article find links to article
from the vessels most prone to dissection and rupture. In 2019, a new drug application (NDA) for celiprolol was denied by the U.S. Food and Drug Administration
Antibe Therapeutics (1,091 words) [view diff] case mismatch in snippet view article find links to article
drug Otenaproxesul. On March 29, 2021, the drug's Investigational New Drug application was cleared by the US Food and Drug Administration, allowing for
Clinical research (989 words) [view diff] case mismatch in snippet view article find links to article
label use are submitted to the FDA in support of an Investigational New Drug application. Where devices are concerned the submission to the FDA would be for
Palovarotene (1,264 words) [view diff] case mismatch in snippet view article find links to article
refuse marketing authorization for Sohonos. Clementia submitted a new drug application for palovarotene for the treatment of fibrodysplasia ossificans progressiva
Faropenem (431 words) [view diff] case mismatch in snippet view article find links to article
States Food and Drug Administration (FDA) on 20 December 2005. The new drug application dossier submitted included these proposed indications:[citation needed]
Cocaine esterase (856 words) [view diff] case mismatch in snippet view article find links to article
200 mg, i.v. solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. TNX-1300 (formerly
Tositumomab (685 words) [view diff] case mismatch in snippet view article find links to article
with unlabelled antibody.: 21  Following a first investigational new drug application in 1989 and biologics license application in 2000, Bexxar was approved
Metoclopramide (3,453 words) [view diff] exact match in snippet view article find links to article
"New Drug Application (NDA): 017862 - Approval history - Hikma Metoclopramide Hydrochloride". U.S. Food and Drug Administration. "New Drug Application
Cubist Pharmaceuticals (539 words) [view diff] exact match in snippet view article find links to article
Retrieved 2017-10-31. "Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review | FierceBiotech". www.fiercebiotech.com. 30
Sitaxentan (711 words) [view diff] exact match in snippet view article find links to article
6.1860. PMID 12065350. "Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension". July 2005. "Primary or Unexplained
Methylcobalamin (836 words) [view diff] exact match in snippet view article find links to article
3344/kjp.2018.31.3.183. PMC 6037815. PMID 30013732. "Eisai Submits New Drug Application for Mecobalamin Ultra-High Dose Preparation as Treatment for Amyotrophic
Trelagliptin (659 words) [view diff] exact match in snippet view article find links to article
(2): 125–32. doi:10.1016/s2213-8587(13)70149-9. PMID 24622716. "New Drug Application Approval of Zafatek® Tablets for the treatment of Type 2 Diabetes
Antidepressants in Japan (1,095 words) [view diff] exact match in snippet view article find links to article
Lexapro approval in Japan". Reuters. "Takeda and Lundbeck Submit New Drug Application (NDA) for Vortioxetine in Japan for the Treatment of Major Depressive
Clinafloxacin (826 words) [view diff] case mismatch in snippet view article find links to article
Clinafloxacin has not been approved for any indication. The investigational new drug application was withdrawn by the manufacturer in 1999, citing safety concerns
CSL Vifor (1,960 words) [view diff] exact match in snippet view article find links to article
the US Food and Drug Administration FDA approved a Supplemental New Drug Application for the potassium binder Veltassa with or without food In 2019, Vifor
ViroPharma (760 words) [view diff] exact match in snippet view article find links to article
trials did not demonstrate efficacy. In 2001, ViroPharma submitted a New Drug Application of pleconaril to the FDA for the common cold. On 2002-03-19, the
Oxaprozin (881 words) [view diff] case mismatch in snippet view article find links to article
price was comparable to other prescription NSAIDs. The oxaprozin new drug application (NDA 18-841) was submitted to the FDA on August 10, 1982. The drug
Amatuximab (954 words) [view diff] exact match in snippet view article find links to article
Cancer Institute. Quickly following they opened an Investigational New Drug Application with the FDA in 2006 and initiated Phase I clinical trials. In November
Viralytics (2,428 words) [view diff] case mismatch in snippet view article find links to article
Stage Melanoma'. This trial took place under an Investigational New Drug application. The trial completed in 2015 with favourable results and multiple
PARP inhibitor (2,052 words) [view diff] exact match in snippet view article find links to article
for ovarian cancer July 2020 "BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China | Seeking Alpha". "Study
Conivaptan (805 words) [view diff] case mismatch in snippet view article find links to article
Pharmaceuticals and marketed by Astellas. Yamanouchi Pharmaceuticals filed a new drug application to the FDA for conivaptan hydrochloride to treat hyponatremia on
Dronabinol (2,219 words) [view diff] exact match in snippet view article find links to article
dronabinol drug Adversa®, which are both in the accelerated 505(b)(2) New Drug Application (NDA) pathway for the U.S. and Canadian markets. In the United States
Cyclamate (1,488 words) [view diff] exact match in snippet view article find links to article
Laboratories, which undertook the necessary studies and submitted a New Drug Application in 1950. Abbott intended to use cyclamate to mask the bitterness
Genta (company) (3,528 words) [view diff] exact match in snippet view article
the Phase 3 melanoma trial, both companies favored submission of a New Drug Application, which was not approved by FDA in 2004. Aventis and Genta terminated
Rett syndrome (6,310 words) [view diff] case mismatch in snippet view article find links to article
treatment of Rett syndrome. In September 2022, the FDA accepted a new drug application for trofinetide and granted it priority review. In March 2023 the
Young Living (1,991 words) [view diff] case mismatch in snippet view article find links to article
product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as
Keystone Nano (257 words) [view diff] case mismatch in snippet view article find links to article
activity. In January 2017, the FDA approved the investigational new drug application, NanoLiposome, to assess the product as a form of treatment for solid
Hydralazine (1,354 words) [view diff] exact match in snippet view article find links to article
doi:10.3181/00379727-73-17591. PMID 15402536. S2CID 32603042. "New Drug Application (NDA) 008303 Company: NOVARTIS Drug Name(s): Apresoline". FDA. Archived
Discovery and development of dipeptidyl peptidase-4 inhibitors (5,084 words) [view diff] case mismatch in snippet view article find links to article
6). In June 2008 AstraZeneca and Bristol-Myers Squibb submitted a new drug application for Onglyza in the United States and a marketing authorization application
Ibuprofen (5,851 words) [view diff] exact match in snippet view article find links to article
Archived from the original on 15 August 2013. Retrieved 20 March 2014. "New Drug Application (NDA): 017463". U.S. Food and Drug Administration (FDA). Archived
Pyridoxamine (1,517 words) [view diff] exact match in snippet view article find links to article
grounds that pyridoxamine, as the subject of an Investigational New Drug Application with the FDA, is a drug and not a dietary supplement. This petition
Pyridoxamine (1,517 words) [view diff] exact match in snippet view article find links to article
grounds that pyridoxamine, as the subject of an Investigational New Drug Application with the FDA, is a drug and not a dietary supplement. This petition
Anidulafungin (1,045 words) [view diff] exact match in snippet view article find links to article
"Anidulafungin" (PDF). EMA Europa. 2007. "Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia"
Aminophylline (1,127 words) [view diff] exact match in snippet view article find links to article
350 mg tab Minomal SR 600 mg tab "FDA-Approved Drugs Abbreviated New Drug Application (ANDA): 087242". fda.gov. October 26, 1983. Retrieved December 2
Belzutifan (1,319 words) [view diff] exact match in snippet view article find links to article
Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)" (Press release). Merck
4-Chlorokynurenine (780 words) [view diff] case mismatch in snippet view article find links to article
when it acquired Artemis in 2003. VistaGen filed an Investigational New Drug application with the FDA for use of AV-101 in neuropathic pain in 2013. In 2013
Ionis Pharmaceuticals (1,420 words) [view diff] case mismatch in snippet view article find links to article
approval by the Food and Drug Administration for an investigational new drug application in 1992 for a genital warts drug candidate. The FDA approval marked
Astellas Institute for Regenerative Medicine (843 words) [view diff] case mismatch in snippet view article find links to article
February 2015. On November 30, 2010, Ocata filed an Investigational New Drug application with the U.S. FDA for the first clinical trial using embryonic stem
Gerovital (759 words) [view diff] case mismatch in snippet view article find links to article
as "a new drug within the meaning of 201(p), without an approved new drug application [Unapproved New Drug, Section 505(a)]." The ban covers: Gerovital
Alosetron (1,502 words) [view diff] exact match in snippet view article find links to article
On June 7, 2002, the FDA announced the approval of a supplemental New Drug Application (sNDA) that allows restricted marketing of Lotronex (alosetron hydrochloride)
Federal Analogue Act (1,175 words) [view diff] case mismatch in snippet view article find links to article
controlled substance; (ii) any substance for which there is an approved new drug application; (iii) with respect to a particular person any substance, if an exemption
Adalimumab (6,899 words) [view diff] case mismatch in snippet view article find links to article
US$1 billion in annual sales for the first time. 2005: Eisai submits new drug application for adalimumab (D2E7) in Japan. 2006: Submitted Humira for the Crohn's
Panobinostat (1,282 words) [view diff] exact match in snippet view article find links to article
Retrieved 22 October 2022. "Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for Farydak (panobinostat) Capsules, 10 Milligrams, 15 Milligrams
Tadalafil (3,238 words) [view diff] case mismatch in snippet view article find links to article
as a treatment for ED. Two years later, Lilly ICOS, LLC, filed a new drug application with the FDA for compound IC351 (under the tadalafil generic name
Dorzolamide/timolol (1,186 words) [view diff] case mismatch in snippet view article find links to article
was the first of many generic competitors to submit an abbreviated new drug application (ANDA) for dorzolamide hydrochloride/timolol maleate eye drops. Hi-Tech
Trehalose (2,685 words) [view diff] exact match in snippet view article find links to article
Ataxia". MPR. Retrieved 14 November 2023. "FDA Accepts Investigational New Drug Application and Grants Fast Track Designation of Trehalose for Spinocerebellar
Eravacycline (1,528 words) [view diff] exact match in snippet view article find links to article
IGNITE4 will become available as the company prepares to submit its New Drug Application (NDA) in the first quarter of 2018 for Eravacycline treatment of
Dronedarone (2,136 words) [view diff] exact match in snippet view article find links to article
dronedarone use at the time of cardioversion. Originally submitted as a New Drug Application in 2005, dronedarone was reviewed and recommended for approval in
Ceritinib (1,239 words) [view diff] exact match in snippet view article find links to article
use of crizotinib. In February 2017, the FDA accepted a supplement New Drug Application for ceritinib and granted Priority Review for expanded use of ceritinib
Cynapsus Therapeutics (435 words) [view diff] exact match in snippet view article find links to article
value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates out-licensing
Christoph Westphal (2,971 words) [view diff] case mismatch in snippet view article find links to article
on the promise of that data acquired by Alnara. Lilly submitted a new drug application to the FDA in 2011, which the FDA rejected, finding no clear benefit
Lixisenatide (1,918 words) [view diff] exact match in snippet view article find links to article
Inks Deal with Hanmi Pharma Worth 4 2 Billion". Biospace. "Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA". Drugs.com/PR Newsire
Vigabatrin (2,435 words) [view diff] exact match in snippet view article find links to article
announced that the US Food and Drug Administration had granted two New Drug Application approvals for vigabatrin. The drug is indicated as monotherapy for
Irinotecan (2,315 words) [view diff] exact match in snippet view article find links to article
May 2016. Retrieved 1 September 2017. Temple R (22 October 1998). "New Drug Application" (PDF). U.S. Food and Drug Administration (FDA). Letter to Walker
Von Hippel–Lindau disease (2,101 words) [view diff] exact match in snippet view article find links to article
Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)" (Press release). Merck
Agios Pharmaceuticals (524 words) [view diff] case mismatch in snippet view article find links to article
first cancer drug, Enasidenib In December 2017, the company filed a new drug application, or NDA, with the U.S. Food and Drug Administration, or FDA, for
Von Hippel–Lindau disease (2,101 words) [view diff] exact match in snippet view article find links to article
Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)" (Press release). Merck
Trihexyphenidyl (1,928 words) [view diff] exact match in snippet view article find links to article
Licence". www.ebs.tga.gov.au. Retrieved 2020-08-20. FDA (2003-05-25). "New Drug Application Approval Notice" (PDF). Retrieved 2020-08-20. World Health Organization
FTC v. Actavis, Inc. (2,952 words) [view diff] exact match in snippet view article find links to article
generic for the market. Respondent Solvay Pharmaceuticals filed a New Drug Application in 1999 and received a patent in 2003 for its brand-name drug, Androgel
Dalbavancin (1,835 words) [view diff] exact match in snippet view article find links to article
(EMA) assessment of dalbavancin "Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration". Drugs.com
Escitalopram (4,438 words) [view diff] case mismatch in snippet view article find links to article
Laboratories. Its development was initiated in 1997, and the resulting new drug application was submitted to the US FDA in March 2001. The short time (3.5 years)
Vincristine (2,816 words) [view diff] exact match in snippet view article find links to article
9 June 2020. "Acrotech Biopharma LLC; Withdrawal of Approval of New Drug Application for MARQIBO (VinCRIStine Sulfate LIPOSOME Injection), 5 milligrams/5
Condoliase (341 words) [view diff] exact match in snippet view article find links to article
doi:10.3171/2017.7.SPINE161327. PMID 29424676. "Seikagaku Announces New Drug Application Approval of HERNICORE 1.25 Units for Intradiscal Injection in Japan
Oleoyl-estrone (909 words) [view diff] case mismatch in snippet view article find links to article
licensed to Manhattan Pharmaceuticals in 2002. An Investigational New Drug application was accepted by the U.S. Food and Drug Administration (FDA) in 2005
Anecortave acetate (733 words) [view diff] exact match in snippet view article find links to article
need. This allowed Retaane to file with the FDA using a “rolling” New Drug Application, which allows specific units, Chemistry, Manufacturing, and Controls
Ruth Arnon (1,563 words) [view diff] case mismatch in snippet view article find links to article
(London), and the Curie Institute (Paris). Arnon and Sela developed a new drug application for the treatment of multiple sclerosis called Copolymer 1. Its chemical
Cariprazine (2,585 words) [view diff] exact match in snippet view article find links to article
December 2018. Retrieved 6 December 2018. "AbbVie Submits Supplemental New Drug Application to U.S. FDA for cariprazine (major depressive disorder) for the Adjunctive
Tofacitinib (3,189 words) [view diff] exact match in snippet view article find links to article
Letter from FDA for Oral Xeljanz (tofacitinib citrate) Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis" (Press release)
Saxagliptin (1,961 words) [view diff] exact match in snippet view article find links to article
blood sugar (hypoglycemia) is low with saxagliptin monotherapy. A New Drug Application for saxagliptin in the treatment of type 2 diabetes was submitted
Propylene glycol (4,679 words) [view diff] exact match in snippet view article find links to article
Pharmacopoeia) propylene glycol can reduce the risk of Abbreviated New Drug Application (ANDA) rejection. Propylene glycol can also be obtained from glycerol
Methylhexanamine (3,718 words) [view diff] exact match in snippet view article find links to article
Cyclopentamine Deterenol Levomethamphetamine Pseudoephedrine The N.D.A (New Drug Application) for methylhexanamine was withdrawn in 1983. Consequently, any product
Nirmatrelvir/ritonavir (5,751 words) [view diff] exact match in snippet view article find links to article
"Pfizer Reports Additional Data on Paxlovid Supporting Upcoming New Drug Application Submission to U.S. FDA". New York. 14 June 2022. Archived from the
Compounding (3,493 words) [view diff] no match in snippet view article find links to article
of FDA-approved drugs, without an FDA-sanctioned, investigational new-drug application Receiving, storing, or using drug substances without first obtaining
Patiromer (1,152 words) [view diff] exact match in snippet view article find links to article
information was submitted to the FDA in the form of a supplemental New Drug Application (sNDA) and as a result, in November 2016 the FDA approved the removal
Rosetta@home (8,568 words) [view diff] case mismatch in snippet view article find links to article
2020, Neoleukin announced it would be submitting an Investigational New Drug application with the Food and Drug Administration in order to begin a Phase 1
Documentum (1,226 words) [view diff] exact match in snippet view article find links to article
a pharmaceutical vendor, to automate the process of assembling New Drug Application (NDA) documents when seeking approval from the U.S. Food and Drug
Promazine (678 words) [view diff] exact match in snippet view article find links to article
p. 535. ISBN 978-1-138-00968-4. "Drugs@FDA: FDA-Approved Drugs". New Drug Application (NDA): 010942 Sparine. U.S. Food and Drug Administration. Hendrickson
Clomifene (4,861 words) [view diff] exact match in snippet view article find links to article
indications. Clinical studies were conducted under an Investigational New Drug Application; clomifene was third drug for which an IND had been filed under the
OvaScience (727 words) [view diff] case mismatch in snippet view article find links to article
2013 the FDA ruled that it would need to file an investigational new drug application before it could start marketing the service; OvaScience's shares
Disulfiram (2,913 words) [view diff] exact match in snippet view article find links to article
Toxicologica. 4 (3–4): 285–296. doi:10.1111/j.1600-0773.1948.tb03350.x. "New Drug Application (NDA) 007883: Disulfiram (Antabuse)". FDA-Approved Drugs. U.S. Food
Arcturus Therapeutics (1,787 words) [view diff] case mismatch in snippet view article find links to article
April 13, 2020, it was announced that the company's investigational new drug application for Phase 1b study in patients with OTCD was allowed to proceed by
Prussian blue (4,822 words) [view diff] exact match in snippet view article find links to article
capsules, when manufactured under the conditions of an approved New Drug Application, can be found safe and effective therapy" in certain poisoning cases
Investigator's brochure (606 words) [view diff] exact match in snippet view article find links to article
Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application [2] Code of Federal Regulations, Title 21, Part 201.56 (and Part
Product lifecycle (4,788 words) [view diff] case mismatch in snippet view article find links to article
a given compound is a key element of the regulatory filing for a new drug application. As such, PPLM seeks to manage information around the development
Akorn (495 words) [view diff] exact match in snippet view article find links to article
for an acquisition. In October 2018, Akorn received Abbreviated New Drug Application (ANDA) approval from Food and Drug Administration (FDA) for Bimatoprost
Friedreich's ataxia (5,038 words) [view diff] case mismatch in snippet view article find links to article
Nrf2 is decreased in FRDA cells. In May 2022, the FDA accepted a new drug application for omaveloxolone and granted it priority review. Omaveloxolone received
Takeda Oncology (1,243 words) [view diff] case mismatch in snippet view article find links to article
December 2007, Millennium successfully submitted a supplemental new drug application (sNDA) to the FDA for Velcade for previously untreated multiple myeloma
Friedreich's ataxia (5,038 words) [view diff] case mismatch in snippet view article find links to article
Nrf2 is decreased in FRDA cells. In May 2022, the FDA accepted a new drug application for omaveloxolone and granted it priority review. Omaveloxolone received
Ivermectin (7,538 words) [view diff] exact match in snippet view article find links to article
three drugs are equally safe and effective for treating ascariasis. New Drug Application Identifier: 50-742/S-022 "Search Page – Drug and Health Product Register"
Hypoxia-inducible factor (4,911 words) [view diff] exact match in snippet view article find links to article
Retrieved 25 April 2021. "Merck Receives Priority Review From FDA for New Drug Application for HIF-2α Inhibitor Belzutifan (MK-6482)" (Press release). Merck
Henry I. Miller (1,505 words) [view diff] exact match in snippet view article find links to article
officer in charge of Humulin [human insulin] at the F.D.A." during its New Drug Application review in 1982. From 1985 to 1989, he was a special assistant to
Gamma-Hydroxybutyric acid (8,754 words) [view diff] case mismatch in snippet view article find links to article
as a company called Orphan Medical had filed an investigational new drug application and was running clinical trials with the intention of gaining regulatory
Imatinib (6,513 words) [view diff] case mismatch in snippet view article find links to article
received FDA approval in May 2001, only two and a half years after the new drug application was submitted. On the same month it made the cover of TIME magazine
Methysergide (2,291 words) [view diff] case mismatch in snippet view article find links to article
S2CID 22433355. Friedman Y. "Sansert / methysergide maleate FDA New drug application 012516 international drug patent coverage, generic alternatives and
Small interfering RNA (6,761 words) [view diff] case mismatch in snippet view article find links to article
siRNAs, lumasiran (ALN-GO1) and inclisiran, have been submitted for new drug application to the FDA. Several siRNAs are undergoing phase 3 clinical studies
Fluoxetine (11,644 words) [view diff] case mismatch in snippet view article find links to article
Company, a division of Eli Lilly & Company, filed an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for fluoxetine. Fluoxetine
Recreational use of dextromethorphan (3,277 words) [view diff] case mismatch in snippet view article find links to article
Federal Analog Act does not apply to dextromethorphan because a new drug application has been filed for it.[citation needed] Dissociative drug Nitrous
IBM hexadecimal floating-point (2,196 words) [view diff] exact match in snippet view article find links to article
(.XPT) as required by the Food and Drug Administration (FDA) for New Drug Application (NDA) study submissions, GRIB (GRIdded Binary) data files to exchange
Bausch Health (5,134 words) [view diff] case mismatch in snippet view article find links to article
decision bolsters his previous ruling that Norwich's abbreviated new drug application for rifaximin infringed on Bausch Health's Xifaxan patents for the
Immunoglobulin therapy (5,473 words) [view diff] exact match in snippet view article find links to article
original on 7 June 2013. "FDA Approves Octapharma USA Investigational New Drug Application for Severe COVID-19 Patients". www.businesswire.com. 20 May 2020
Triclosan (6,609 words) [view diff] exact match in snippet view article find links to article
without these ingredients, take them off the market or submit a New Drug Application (NDA) for the products. The 19 ingredients are: Cloflucarban Fluorosalan
Abaloparatide (1,919 words) [view diff] exact match in snippet view article find links to article
3 November 2017. "Radius Announces FDA Acceptance for Filing of New Drug Application for Abaloparatide-SC for the Treatment of Postmenopausal Women with
Rosiglitazone (5,929 words) [view diff] exact match in snippet view article find links to article
Administration. Retrieved 30 March 2014. "Medical Officer's Review of New Drug Application 21-071: Rosiglitazone (Avandia)" (PDF). April 19, 1999. Retrieved
Mutual Pharmaceutical Co. v. Bartlett (790 words) [view diff] no match in snippet view article find links to article
new brand name drug is created, the drug must be submitted under a New-Drug Application (NDA). In the NDA is a compilation of materials that must include
Digital medicine (916 words) [view diff] exact match in snippet view article find links to article
510(k) clearances. The ingestible sensor is CE marked in Europe. A New Drug Application for the first fully integrated pharmaceutical with ingestible sensor
Seagen (3,140 words) [view diff] case mismatch in snippet view article find links to article
in collaboration with Bayer for the submission of investigational new drug application with the FDA 5 October: discontinuation of Phase IIb trial with dazcetuzumab
NcRNA therapy (5,353 words) [view diff] exact match in snippet view article find links to article
Center for Drug Evaluation and (7 December 2021). "Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products
Levonorgestrel (7,957 words) [view diff] exact match in snippet view article find links to article
2015-09-26. "Levonorgestrel 1.5 mg Tablet Emergency Contraceptive: New Drug Application 21998, Supplement 5" (PDF). U.S. Food and Drug Administration. "Now
History of the Food and Drug Administration (3,393 words) [view diff] exact match in snippet view article find links to article
manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate
Sunscreen (11,980 words) [view diff] exact match in snippet view article find links to article
Acid 10% EU, AUS (US: approved in certain formulations up to 3% via New Drug Application (NDA) Route) Protects against skin tumors in mice X Titanium dioxide
Ozanimod (3,240 words) [view diff] case mismatch in snippet view article find links to article
determined that the nonclinical and clinical pharmacology sections in the new drug application are insufficient to permit a complete review, the company said. Staines
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (3,818 words) [view diff] case mismatch in snippet view article find links to article
ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive: (1)
Declaration of Helsinki (7,202 words) [view diff] case mismatch in snippet view article find links to article
Foreign clinical studies not conducted under an investigational new drug application. Final Rule April 28 2008, effective October 27 2008". Archived from
Vosoritide (1,351 words) [view diff] exact match in snippet view article find links to article
(4): 539. 2014. "Food and Drug Administration Accepts BioMarin's New Drug Application for Vosoritide to Treat Children with Achondroplasia" (Press release)
Food and Drug Administration Safety and Innovation Act (2,764 words) [view diff] case mismatch in snippet view article find links to article
October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional
Treatment of Rett syndrome (3,050 words) [view diff] case mismatch in snippet view article find links to article
greater number of participants and over a longer time scale and a new drug application for Trofinetide was submitted to the FDA in mid 2022 and accepted
Conjugated estrogens (6,452 words) [view diff] exact match in snippet view article find links to article
activity of Premarin, and it laid the groundwork for Abbreviated New Drug Application (ANDA) submissions of generic versions. In 1984 an NIH consensus
Gene therapy (17,769 words) [view diff] case mismatch in snippet view article find links to article
Committee. Researchers seeking federal funds for an investigational new drug application, (commonly the case for somatic human genetic engineering,) must
Niemann–Pick disease, type C (5,123 words) [view diff] exact match in snippet view article find links to article
July 17, 2021, the US Food and Drug Administration rejected the New Drug Application for Arimoclomol, and issued a complete response letter to the company
Enobosarm (12,745 words) [view diff] case mismatch in snippet view article find links to article
cancer. In January 2024, Veru Inc. submitted an Investigational New Drug application to the FDA of enobosarm for prevention of muscle loss and augmentation
Norelgestromin/ethinylestradiol (462 words) [view diff] exact match in snippet view article find links to article
Transdermal System), 150 mcg/35 mcg per day" (PDF). Abbreviated New Drug Application. U.S. Food and Drug Administration. 16 April 2014. "Ethinyl Estradiol
Mundo Sano (974 words) [view diff] exact match in snippet view article find links to article
S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole 567891011 . This is the first drug ever approved
John J. Zhang (1,539 words) [view diff] case mismatch in snippet view article find links to article
mitochondrial transfer techniques in humans, and requires an Investigational New Drug application. In contrast, the UK became the first country to legalize it, in
Troriluzole (261 words) [view diff] exact match in snippet view article find links to article
bioavailability. Meglio, Marco (25 June 2023). "Biohaven Submits New Drug Application for Troriluzole as Spinocerebellar Ataxia Type 3 Therapy". NeurologyLive
Criticism of the Food and Drug Administration (5,595 words) [view diff] case mismatch in snippet view article find links to article
Amendment, the average time from the filing of an investigational new drug application (IND) to approval was 7 months. By 1998, it took an average of 7
United States biological defense program (5,199 words) [view diff] case mismatch in snippet view article find links to article
submitted to the U.S. Food and Drug Administration an Investigational New Drug application for a Q fever vaccine. In the following decade, the US accumulated
Symphogen (1,527 words) [view diff] case mismatch in snippet view article find links to article
development of Sym002, which allows submission of an Investigational New Drug application for new safety studies. Recombinant monoclonal antibody mixtures
Medical cannabis in the United States (12,552 words) [view diff] case mismatch in snippet view article find links to article
petition to the FDA is submitted in the form of an Investigational New Drug application, which the FDA has 30 days to respond to. DEA research registrations
Apricus Biosciences (1,295 words) [view diff] exact match in snippet view article find links to article
well as the lead contributor for all medical review of the Qsymia New Drug Application and was the lead medical presenter at the successful Qsymia FDA Advisory
Novartis v. Union of India & Others (5,296 words) [view diff] exact match in snippet view article find links to article
Investigational New Drug Application (IND # 55,666) for Gleevec was filed on 9 April 1998 and on 27 February 2001, the original New Drug Application (FDA Drug
Richard Pestell (2,735 words) [view diff] no match in snippet view article find links to article
the preclinical reference citation in the IND (investigational new drug) application to the FDA for the initial clinical research programs (palbocicilib
Discovery and development of TRPV1 antagonists (4,635 words) [view diff] exact match in snippet view article find links to article
2009-10-20. "NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application". Archived from the original on 2009-11-12. Retrieved 2009-11-06
Christopher Busby (5,265 words) [view diff] exact match in snippet view article find links to article
Evaluation and. "Bioterrorism and Drug Preparedness – FDA Approves First New Drug Application for Treatment of Radiation Contamination due to Cesium or Thallium
Estradiol (medication) (15,421 words) [view diff] exact match in snippet view article
on 18 August 2020. Retrieved 10 June 2022. "FDA-Approved Drugs, New Drug Application 010753". Drugs@FDA. Archived from the original on 21 March 2021.
MDMA-assisted psychotherapy (2,827 words) [view diff] exact match in snippet view article find links to article
from 18 different phase 2 and phase 3 studies with plans to file a New Drug Application with the FDA. MAPS hopes to receive FDA approval by the end of 2024
Cost of drug development (1,690 words) [view diff] exact match in snippet view article find links to article
three phases, the pharmaceutical company can move forward with a New Drug Application from the FDA. In 2014, the FDA charged between $1 million to $2 million
List of Guidances for Statistics in Regulatory Affairs (3,027 words) [view diff] case mismatch in snippet view article find links to article
submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application
Pharmaceutical industry in China (12,120 words) [view diff] case mismatch in snippet view article find links to article
seriously non compliant with GMP. There is only federal regulation on new drug application, but there are both local regulation and national regulation regarding
List of progestogens available in the United States (2,291 words) [view diff] exact match in snippet view article find links to article
2024-03-17. Murry, Karen (July 13, 2023). "Decisional Memorandum New Drug Application 17031 Supplement 41 Application for Full Prescription-to-Nonprescription
CDKL5 deficiency disorder (2,202 words) [view diff] exact match in snippet view article find links to article
from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)"
Eplontersen (473 words) [view diff] exact match in snippet view article find links to article
Retrieved 26 February 2024. "Ionis announces FDA acceptance of New Drug Application for eplontersen for the treatment of hereditary transthyretin-mediated
No nit policy (5,378 words) [view diff] exact match in snippet view article find links to article
Products: New Drug Application (NDA): 087266". FDA. "Lindane Shampoo, USP, 1%" (PDF). FDA. "Drugs@FDA: FDA Approved Drug Products: New Drug Application (NDA):
Gender disparities in health (11,429 words) [view diff] exact match in snippet view article find links to article
Data for Certain Subgroups of the Population in Investigational New Drug Application Reports and New Drug Applications" regulations mandated that drug
Multiple sclerosis drug pipeline (9,409 words) [view diff] case mismatch in snippet view article find links to article
In July 2021, the FDA gave the go-ahead for an investigational new drug application (IND) for the phase 3 ENSURE program, which will evaluate IMU-838
Anil Potti (4,834 words) [view diff] case mismatch in snippet view article find links to article
initiation, and concluded that the study would require an Investigational New Drug application, which had not been submitted. An FDA audit in 2011 further showed
List of MeSH codes (E05) (5,386 words) [view diff] case mismatch in snippet view article
500 – multicenter studies MeSH E05.337.300.400 – investigational new drug application MeSH E05.337.550.200 – drug screening assays, antitumor MeSH E05
Cancer epigenetics (12,530 words) [view diff] exact match in snippet view article find links to article
21 (1): 103–107. doi:10.1038/5047. PMID 9916800. S2CID 25070861. "New Drug Application: Panobinostat" (PDF). Center for Drug Evaluation and Research. U
Tonix Pharmaceuticals (5,272 words) [view diff] case mismatch in snippet view article find links to article
(formerly known as RBP-8000) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. TNX-1300 is a recombinant
Biopure (2,404 words) [view diff] case mismatch in snippet view article find links to article
in-hospital trauma trial designation as a separate investigational new drug application (INDA) from the pending biologic license application (BLA) for orthopedic
Massachusetts v. Purdue (3,602 words) [view diff] exact match in snippet view article find links to article
221–227. doi:10.2105/AJPH.2007.131714. PMC 2622774. PMID 18799767. New Drug Application to FDA for OxyContin, Pharmacology Review: 'Abuse Liability of Oxycodone
Timeline of the opioid epidemic (4,346 words) [view diff] exact match in snippet view article find links to article
221–227. doi:10.2105/AJPH.2007.131714. PMC 2622774. PMID 18799767. New Drug Application to FDA for OxyContin, Pharmacology Review: 'Abuse Liability of Oxycodone