New Drug Applications Archive
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News Archive for October 2009
October 2, 2009
- Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD
- Discovery Labs and FDA Establish Path for Potential Surfaxin Approval
- Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States
October 5, 2009
October 6, 2009
October 12, 2009
October 14, 2009
October 21, 2009
- FDA Issues Complete Response Letter for CorVue
- Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)
October 22, 2009
- Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
- Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta
