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New Drug Applications Archive - December 2014

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December 5, 2014

Anti-Infective Advisory Committee Recommends Approval Of Actavis' Ceftazidime-Avibactam

December 6, 2014

Opdivo (nivolumab) Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma

December 9, 2014

Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research

December 11, 2014

Jazz Pharmaceuticals Initiates Rolling NDA Submission For Defibrotide For The Treatment Of Severe Hepatic Veno-Occlusive Disease

December 14, 2014

Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (vemurafenib) in Advanced Melanoma

December 15, 2014

December 17, 2014

Pozen’s Yosprala Receives Complete Response Letter from the FDA

December 23, 2014

December 24, 2014

Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension

December 29, 2014

December 30, 2014

Alexion Completes Rolling BLA Submission to FDA for Asfotase Alfa for Hypophosphatasia

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