New Drug Applications Archive - June 2010
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June 1, 2010
June 3, 2010
June 7, 2010
- OPAXIO Phase II Study Results Confirm High Rate of Complete Response with Low Rate of Side Effects in Patients with Advanced Esophageal Cancer
- Theratechnologies announces positive vote by FDA Advisory Committee for tesamorelin
June 8, 2010
- Depomed Announces Acceptance of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796
- Merck Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy
- Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval
June 10, 2010
June 11, 2010
- H. Lundbeck A/S (DK) - Lundbeck will submit an NDA for clobazam for patients with Lennox-Gastaut syndrome with the FDA before year end 2010
- FDA Advisory Committee Unanimously Recommends Approval Of Novartis Investigational Treatment FTY720 To Treat Relapsing Remitting MS
June 14, 2010
June 15, 2010
- Orexo confirms Abstral PDUFA date update
- Orexigen Therapeutics Announces FDA Acceptance of Contrave New Drug Application for the Treatment of Obesity
