New Drug Applications: June 2007

June 1	Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol
June 1	Abbott Submits XIENCE V Everolimus Eluting Coronary Stent System Application for U.S. FDA Approval
June 1	Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge
June 5	Biovest to File for Accelerated Conditional Approval of BiovaxID
June 5	Abilify (aripiprazole) Supplemental New Drug Application for Pediatric Patients With Schizophrenia Accepted for Priority Review by the U.S. Food and Drug Administration
June 5	Avalere Health Compares FDA Review of Several Categories of Drugs Including Alzheimer's Disease
June 6	Nuvo Continues Discussions with the FDA Related to Pennsaid
June 6	New Drug Application Submitted for Investigational Antibiotic Doripenem
June 8	Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS
June 11	FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer
June 11	Pro-Pharmaceuticals Submits Data to Begin a 505 (b)(2) Filing with the FDA for a New Formulation of Irinotecan to be Co-administered with Davanat as a Functional Excipient
June 11	GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program
June 12	Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency
June 12	FDA Grants Priority Review for Oral Formulation of Hycamtin (topotecan) to Treat Relapsed Small Cell Lung Cancer
June 13	Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules
June 13	FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors
June 14	Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA
June 14	Solvay Pharmaceuticals, Inc. Announces Submission of Supplemental New Drug Application for AndroGel in Male Adolescents
June 18	FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)
June 19	FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
June 19	Nuvo Provides Update on Discussions with the FDA Related to Pennsaid Approval
June 20	Inspire and FAES Farma Amend Bilastine Licensing Agreement
June 20	Genzyme Files for Approval of Single-Treatment Synvisc-One
June 21	Shire Receives Approvable Letter From FDA for Intuniv (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
June 21	Merck Provides Update on Status of Supplemental Biologics License Applications for Gardasil
June 21	Pfizer Receives Approvable Letter From FDA For Maraviroc
June 21	FDA Issues Approvable Letter for Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
June 27	Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer
June 27	AVANT's Partner, GlaxoSmithKline, Files Rotarix Application for U.S. Marketing Approval with the FDA
June 27	Taxotere (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Prior to Chemoradiotherapy and Surgery
June 27	FDA Priority Review Granted for Isentress (raltegravir), Merck's Investigational Integrase Inhibitor for HIV
June 28	Cephalon Announces Plans for New NDA Filing for Treanda
June 28	Photocure Submits Metvixia NDA to FDA
June 29	Labopharm Meets with FDA to Discuss Second Approvable Letter for Once-daily Tramadol
June 29	Akorn, Inc. Announces the New Drug Application Filing for Akten
June 29	Rimonabant Regulatory Update in the United States
June 29	Shire Announces Filing of Vyvanse (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults

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New Drug Applications: June 2007

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