New Drug Applications Archive
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News Archive for September 2012
September 5, 2012
- FDA Continues Review of Crofelemer New Drug Application beyond PDUFA Goal Date of September 5, 2012
- U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
- NPS Pharmaceuticals Expects to File Natpara BLA in Mid-2013
September 13, 2012
September 19, 2012
September 24, 2012
September 26, 2012
- GSK and Theravance Announce FDA Acceptance of FF/VI New Drug Application (NDA) Submission in the US for COPD
- FDA Acknowledges Receipt of Resubmission of the Eliquis (apixaban) New Drug Application to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation
