New Drug Applications Archive - May 2010
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May 3, 2010
- Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept
- Adventrx to Resubmit ANX-530 NDA in the Fourth Quarter of 2010
May 4, 2010
- King Pharmaceuticals and Acura Pharmaceuticals Announce Plans to Submit an NDA for Acurox Tablets without Niacin
- FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa
May 5, 2010
- Cadence Pharmaceuticals Resubmits New Drug Application for Ofirmev
- InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application
May 6, 2010
May 7, 2010
May 11, 2010
May 13, 2010
May 17, 2010
- Amgen Submits Denosumab Biologics License Application to FDA for the Reduction of Skeletal Related Events in Cancer Patients
- Cadence Pharmaceuticals Announces Ofirmev NDA Action Date of November 4, 2010
- Avanir Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010
- Sigma-Tau Pharmaceuticals Cysteamine Eye Drop NDA Accepted for Filing
May 18, 2010
May 19, 2010
- Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder
- Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval
