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New Drug Applications Archive - December 2016

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December 5, 2016

Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide with the FDA for the Treatment of Type 2 Diabetes

December 8, 2016

Gilead Submits NDA to FDA for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir
Catalyst Pharmaceuticals Provides Update on its Clinical Trial for Patients with Congenital Myasthenic Syndromes

December 9, 2016

Synergy Pharmaceuticals Announces Positive Results in First Phase 3 Trial of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)
US FDA Accepts First Biologics License Application for AstraZeneca’s Durvalumab in Bladder Cancer

December 12, 2016

Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain

December 13, 2016

AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain

December 16, 2016

Adamis Pharmaceuticals Announces NDA Resubmission of Its Epinephrine Pre-Filled Syringe Application to the FDA

December 19, 2016

AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

December 20, 2016

December 21, 2016

Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera, an Investigational Treatment for Neuroendocrine Tumors

December 22, 2016

Elite Provides Update On SequestOx New Drug Application

December 23, 2016

Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban

December 29, 2016

Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs

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