New Drug Applications Archive - July 2013
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July 1, 2013
- Bayer and Onyx Pharmaceuticals Announce Submission of FDA and EMA Applications for Nexavar (sorafenib) for the Treatment of Radioactive Iodine-Refractory Differentiated Thyroid Cancer
- Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia
- FDA Accepts the Filing of The Medicines Company's New Drug Application for Intravenous Antiplatelet Agent Cangrelor
July 9, 2013
- Chelsea Therapeutics Resubmits New Drug Application for Northera (droxidopa) for the Treatment of Symptomatic NOH
- United States Food and Drug Administration Accepts Trimel's NDA for CompleoTRT
- Omthera Pharmaceuticals Announces NDA Submission for Epanova for the Treatment of Patients with Very High Triglycerides
July 10, 2013
- New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies
July 11, 2013
July 16, 2013
July 17, 2013
July 19, 2013
July 24, 2013
- U.S. FDA Arthritis Advisory Committee Votes On Cimzia (certolizumab pegol) For Treatment of Adults with Active Axial Spondyloarthritis, Including Patients with Ankylosing Spondylitis
- Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
- Ligand Signs License Agreement with Ethicor for Oral Lasofoxifene
July 25, 2013
- Sarepta Therapeutics Announces Plans to Submit New Drug Application to FDA for Eteplirsen for the Treatment of Duchenne Muscular Dystrophy in First Half of 2014
- AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S
