FDA New Drug Applications

February 23, 2016

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ViiV Healthcare submits New Drug Application to the FDA for Fostemsavir, an Investigational, First-in-Class Attachment Inhibitor for the Treatment of HIV in Adults with Few Treatment Options Available
Source: FDA New Drug Applications Published on 2019-12-05
Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Source: FDA New Drug Applications Published on 2019-11-26
Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome
Source: FDA New Drug Applications Published on 2019-11-25
Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film
Source: FDA New Drug Applications Published on 2019-11-22
MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis
Source: FDA New Drug Applications Published on 2019-11-20
Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Acceptance of New Drug Application by FDA for RVL-1201 (Oxymetazoline Hydrochloride Ophthalmic Solution, 0.1%) for Acquired Blepharoptosis (Droopy Eyelid)
Source: FDA New Drug Applications Published on 2019-11-20
Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder
Source: FDA New Drug Applications Published on 2019-11-19
US FDA Accepts Regulatory Submission of New Drug Application for Selumetinib in Neurofibromatosis Type 1 (NF1) and Grants Priority Review
Source: FDA New Drug Applications Published on 2019-11-14
Agile Therapeutics Announces FDA Extension of Twirla NDA Review Period
Source: FDA New Drug Applications Published on 2019-11-14
Tricida Announces FDA Acceptance of New Drug Application for Veverimer
Source: FDA New Drug Applications Published on 2019-11-14
Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA
Source: FDA New Drug Applications Published on 2019-11-11
Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD
Source: FDA New Drug Applications Published on 2019-11-11
Cassiopea Announces FDA Acceptance of its New Drug Application for Clascoterone Cream 1%
Source: FDA New Drug Applications Published on 2019-11-08
FDA Grants Braeburn’s Citizen Petition Allowing Brixadi (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
Source: FDA New Drug Applications Published on 2019-11-07
AVEO Oncology Announces Regulatory Update For Tivozanib In Renal Cell Carcinoma
Source: FDA New Drug Applications Published on 2019-11-04

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