New Drug Applications Archive
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June 2007
June 1
June 5
Avalere Health Compares FDA Review of Several Categories of Drugs
Including Alzheimer's Disease
Biovest to File for Accelerated Conditional Approval of BiovaxID
Abilify (aripiprazole) Supplemental New Drug Application for
Pediatric Patients With Schizophrenia Accepted for Priority Review
by the U.S. Food and Drug Administration
June 6
June 11
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
June 13
June 14
June 19
June 20
June 21
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
Bayer and Onyx Submit Supplemental New Drug Application for Nexavar
to 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
