FDA New Drug Applications

February 23, 2016

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Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Source: FDA New Drug Applications Published on 2019-10-17
Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain
Source: FDA New Drug Applications Published on 2019-10-01
Acacia Pharma Announces New Barhemsys PDUFA Target Date
Source: FDA New Drug Applications Published on 2019-09-26
Zogenix Resubmits New Drug Application for Fintepla for the Treatment of Dravet Syndrome to U.S. Food and Drug Administration
Source: FDA New Drug Applications Published on 2019-09-26
MC2 Therapeutics Announces Submission of NDA for Wynzora Cream (Calcipotriene 0.005% and Betamethasone Dipropionate 0.064%) for Treatment of Plaque Psoriasis
Source: FDA New Drug Applications Published on 2019-09-24
Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201
Source: FDA New Drug Applications Published on 2019-09-17
FDA Allergenic Products Advisory Committee Votes to Support the Use of Aimmune’s Palforzia (AR101) for Peanut Allergy
Source: FDA New Drug Applications Published on 2019-09-13
United Therapeutics Announces FDA Acceptance of Trevyent New Drug Application For Review
Source: FDA New Drug Applications Published on 2019-09-11
Intra-Cellular Therapies Provides Lumateperone Regulatory Update
Source: FDA New Drug Applications Published on 2019-09-10
GBT Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease
Source: FDA New Drug Applications Published on 2019-09-05
Tricida Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease
Source: FDA New Drug Applications Published on 2019-09-04
Clearside Biomedical Provides New Drug Application Update for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)
Source: FDA New Drug Applications Published on 2019-08-22
BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
Source: FDA New Drug Applications Published on 2019-08-21
Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%
Source: FDA New Drug Applications Published on 2019-08-20
FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
Source: FDA New Drug Applications Published on 2019-08-20

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