New Drug Applications Archive - April 2008
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April 1, 2008
April 4, 2008
April 8, 2008
April 9, 2008
April 10, 2008
April 14, 2008
- Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA
April 15, 2008
- Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema
- Somaxon Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Silenor for the Treatment of Insomnia
April 22, 2008
- Sciele Pharma Announces FDA Acceptance of NDA for Addrenex Pharmaceuticals' CloniBID to Treat Hypertension
- Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda
April 24, 2008
April 28, 2008
April 29, 2008
- MediQuest Therapeutics Submits New Drug Application to FDA for MQX-503 to treat Raynaud's Disease
- Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
- Acusphere Submits New Drug Application for FDA Approval of Imagify
