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November 2009
November 2
Dendreon Completes Submission of Biologics License Application for Provenge
GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application
November 4
FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
November 5
Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee
November 10
ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status
November 13
Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
November 16
Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application
Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets
November 17
Genzyme Receives Complete Response Letter on Lumizyme Application
November 18
NicOx announces FDA accepts naproxcinod NDA for filing
November 19
AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent
November 22
Dendreon Receives FDA Acknowledgement of Complete Response for Provenge
November 23
FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA
November 24
Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter
November 25
Human Genome Sciences Submits Biologics License Application to FDA for Zalbin
November 30
Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application
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