New Drug Applications: November 2006

November 2	Tercica Reports Somatuline Autogel NDA for Acromegaly Submitted to FDA
November 2	Encysive Submits Complete Response to FDA For Thelin New Drug Application
November 6	FDA Issues Approvable Letter for Entereg (alvimopan) for POI
November 7	Cephalon Inc. Granted Composition of Matter Patent Covering Nuvigil
November 9	Pozen Submits Full Response to FDA Approvable Letter For Trexima
November 10	Merck Responds to FDA-Issued Approvable Letters for Arcoxia (etoricoxib)
November 10	Janssen, L.P. Selects Invega (paliperidone) Extended Release Tablets as Brand Name for Its Investigational Atypical Antipsychotic
November 13	Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer
November 13	Novartis Committed to Making Galvus Available for Patients with Type 2 Diabetes After US Regulators Issue "Approvable Letter"
November 14	FDA Grants Priority Review for Soliris (eculizumab) BLA for Treatment of Paroxysmal Nocturnal Hemoglobinuria
November 16	FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
November 20	Somaxon Pharmaceuticals’ Silenor Demonstrates Positive Results in its Third Phase 3 Clinical Trial in Insomnia
November 21	US FDA Grants Immtech's Oral Drug Candidate Pafuramidine (DB289) Orphan Drug Status for Treatment of PCP
November 22	FDA Approves First Generic Ondansetron Injection
November 27	Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children
November 28	Daiichi Sankyo, Inc. Announces Filing of NDA for Amlodipine Besylate / Olmesartan Medoxomil Combination for the Treatment of Hypertension

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New Drug Applications: November 2006

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