New Drug Applications Archive - August 2015
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August 3, 2015
August 5, 2015
August 6, 2015
August 7, 2015
August 12, 2015
August 17, 2015
- Chiasma Announces FDA Acceptance For Filing of New Drug Application for Octreotide Capsules in Acromegaly
- InSite Vision Announces FDA Acceptance of NDA Filing for BromSite (0.075% bromfenac)
August 19, 2015
- BioMarin Receives Rare Pediatric Disease Designation From FDA for Drisapersen for the Potential Treatment of Duchenne Muscular Dystrophy
- FDA Grants Fast Track Designation to Cempra for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia
August 21, 2015
August 25, 2015
- Amgen Submits New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416)
- Sarepta Therapeutics Announces FDA Has Filed Eteplirsen NDA for the Potential Treatment of Duchenne Muscular Dystrophy for Patients Amenable to Exon 51 Skipping
