New Drug Applications Archive - June 2008
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June 2, 2008
June 3, 2008
June 4, 2008
- Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%
- Indevus Pharmaceuticals Provides Update on Nebido NDA Status
June 6, 2008
June 10, 2008
June 17, 2008
June 18, 2008
June 19, 2008
- Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase)
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter
June 20, 2008
June 23, 2008
- Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for Promacta NDA
- Jerini to Submit Complete Response to the FDA for Icatibant in theTreatment of HAE
June 24, 2008
June 26, 2008
June 27, 2008
- Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture
- Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
June 30, 2008
- New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
- Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
- Introgen Submits Advexin Regulatory Applications in the U.S. and Europe
- GlaxoSmithKline Responds to FDA on Cervarix and Plans to SubmitFinal Study Data for Approval
- Indevus Receives Approvable Letter from FDA for Nebido
- Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease
