New Drug Applications Archive - March 2021
March 1, 2021
- Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy
- Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome
- U.S. FDA Accepts Merck’s Gefapixant New Drug Application for Review
March 2, 2021
- Eyenovia Announces FDA Acceptance of the MydCombi NDA
- Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the FDA
- Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease
March 8, 2021
March 10, 2021
- Kadmon Announces U.S. FDA Has Extended the Review Period for Belumosudil in Chronic Graft-Versus-Host Disease
- FDA Accepts the New Drug Application for Review of Idorsia’s Daridorexant for the Treatment of Adult Patients with Insomnia
March 11, 2021
- Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
- BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
March 15, 2021
March 16, 2021
March 19, 2021
March 25, 2021
March 28, 2021
March 29, 2021
- TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
- Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
March 30, 2021
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