New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

March 2006

March 1

Genasense New Drug Application Accepted for Review by FDA BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA

March 2

UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease

March 6

Tibotec Announces FDA Acceptance for Review of NDA for TMC114

March 7

Altana Submitted New Drug Applications For Ciclesonide Nasal Spray in the U.S. and Canada; Major Milestone in Broadening the Ciclesonide Product Platform FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib

March 10

NPS Receives Approvable Letter for Preos NDA FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response

March 17

Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive

March 22

Novelos Therapeutics Files IND for Novel Hepatitis C Drug; IND Represents Company's Second Clinical Stage Compound

March 23

FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents GlaxoSmithKline Submits Biologics License Application for FDA Approval of FluLaval

March 24

Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin

March 28

Inspire Announces Outcome of FDA Meeting on Dry Eye Program Inspire Announces Outcome of FDA Meeting on Dry Eye Program

March 29

NPS Updates Status of Preos NDA Axcan submits FDA amendment to its new drug application for Helizide

March 30

Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA

March 31

New Drug Application Submitted For RSD1235 Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease

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