New Drug Applications Archive - June 2007
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June 1, 2007
- Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol
- Abbott Submits XIENCE V Everolimus Eluting Coronary Stent System Application for U.S. FDA Approval
- Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge
June 5, 2007
- Abilify (aripiprazole) Supplemental New Drug Application forPediatric Patients With Schizophrenia Accepted for Priority Reviewby the U.S. Food and Drug Administration
- Avalere Health Compares FDA Review of Several Categories of Drugs Including Alzheimer's Disease
- Biovest to File for Accelerated Conditional Approval of BiovaxID
June 6, 2007
- Nuvo Continues Discussions with the FDA Related to Pennsaid
- New Drug Application Submitted for Investigational Antibiotic Doripenem
June 8, 2007
June 11, 2007
- FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer
- 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
- GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program
June 12, 2007
- Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency
- FDA Grants Priority Review for Oral Formulation of Hycamtin(topotecan) to Treat Relapsed Small Cell Lung Cancer
June 13, 2007
- FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors
- Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules
June 14, 2007
- Weight Loss Drug Rimonabant Can Cause Serious Physical and Psychological Harm and Birth Defects, Public Citizen Tells FDA
- Solvay Pharmaceuticals, Inc. Announces Submission of Supplemental New Drug Application for AndroGel in Male Adolescents
June 18, 2007
June 19, 2007
- FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
- Nuvo Provides Update on Discussions with the FDA Related to Pennsaid Approval
June 20, 2007
- Inspire and FAES Farma Amend Bilastine Licensing Agreement
- Genzyme Files for Approval of Single-Treatment Synvisc-One
June 21, 2007
- Shire Receives Approvable Letter From FDA for Intuniv (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
- Merck Provides Update on Status of Supplemental Biologics License Applications for Gardasil
- Pfizer Receives Approvable Letter From FDA For Maraviroc
- FDA Issues Approvable Letter for Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
June 27, 2007
- Bayer and Onyx Submit Supplemental New Drug Application for Nexavarto Treat Liver Cancer
- Taxotere (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Prior to Chemoradiotherapy and Surgery
- AVANT's Partner, GlaxoSmithKline, Files Rotarix Application for U.S. Marketing Approval with the FDA
- FDA Priority Review Granted for Isentress (raltegravir), Merck's Investigational Integrase Inhibitor for HIV
