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Clinical - Approvable Letter
FDA Accepts for Review Theravance, Inc. (THRX)'s Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections 4/27/2009 12:09:09 PM
Discovery Laboratories (DSCO) to File Surfaxin Response in 4 Weeks 9/24/2008 8:23:01 AM
Cardiome Pharma Corp. (COM.TO) And Astellas Pharma Inc. Announce Receipt Of FDA Approvable Letter For KYNAPID(TM) 8/11/2008 8:05:10 AM
Discovery Laboratories (DSCO) Reports Progress in Responding to Surfaxin FDA Approvable Letter 8/6/2008 7:30:48 AM
UCB Group (UCBJF.PK) Receives Not-approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain 7/29/2008 3:55:01 PM
Eisai Corporation of North America Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures; FDA's Not Approvable Letter Outlines Pathway to Potential Approval 7/28/2008 6:18:24 AM
Vanda Pharmaceuticals, Inc. (VNDA) Announces Receipt of Not Approvable Letter From FDA for Iloperidone 7/28/2008 6:42:20 AM
NexMed (NEXM) Receives FDA Non Approvable Letter for ED Product 7/23/2008 6:31:26 AM
Xanodyne Pharmaceuticals, Inc. Receives Approvable Letter From the U.S. FDA for ZIPSOR(TM) Capsules 7/22/2008 6:29:24 AM
Sciele Pharma, Inc. (SCRX) Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment 7/17/2008 6:42:33 AM
FDA (JOBS) Revises Process for Responding to Drug Applications 7/10/2008 6:37:24 AM
Indevus Pharmaceuticals, Inc. (IDEV) Receives Approvable Letter from FDA for NEBIDO(R); Company Announces Revised Operating Plan to Respond to NEBIDO Delay 6/30/2008 8:53:02 AM
Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase) 6/19/2008 6:41:23 AM
Discovery Laboratories (DSCO) Delays Surfaxin Response to FDA 6/19/2008 7:03:32 AM
FDA Requests More Information On Meda AB (SE:MEDAa)'s New Azelastine Formulation 6/4/2008 9:04:51 AM
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