New Drug Applications Archive

New Drug Applications: April 2007

April 2	Cephalon Provides Update Related to Nuvigil New Drug Application
April 2	EPIX Provides Update Regarding Status of Vasovist Appeal
April 3	CSL Biotherapies Submits BLA to Introduce Flu Vaccine to U.S. Market
April 3	IDM Pharma Inc. Announces Oncologic Drugs Advisory Committee Meeting for Junovan (Mifamurtide) Will Take Place on May 9, 2007
April 4	Genta Appeals FDA Decision on Genasense in CLL
April 6	Wyeth Provides Update on FDA Review of the Torisel New Drug Application
April 9	Arthritis Foundation Chief Public Health Officer Testifies at FDA Hearing on Arcoxia
April 10	Endo Comments on Notices Received From Anesiva Regarding Zingo
April 11	Neurochem's Eprodisate (Kiacta) PDUFA Date Extended Three Months by FDA
April 11	Statement by Merck & Co., Inc. Regarding FDA Arthritis Drugs Advisory Committee Meeting on Arcoxia (etoricoxib)
April 11	Pro-Pharmaceuticals Receives Letter from the FDA for New Drug Application for Davanat/ 5-FU
April 12	FDA Advisory Committee Recommends Against Approval for Merck's NDA for Arcoxia (etoricoxib)
April 13	Skyepharma PLC - Once-Daily Requip (ropinirole HCl) XL 24-Hour Extended-Release Tablets Accepted for Filing by U.S. FDA
April 13	Public Citizen: FDA Should Not Approve "Offspring of Vioxx" Painkiller
April 16	FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
April 17	Lung Cancer Alliance Hails FDA Decision to Expedite Review of Xyotax Treatment for Lung Cancer
April 20	Abbott Submits New Drug Application for Simcor Combination Niaspan/Simvastatin Tablet
April 23	Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin Injection to Treat Lung Cancer Brain Metastases
April 24	Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
April 25	FDA Advisory Committee Recommends Accelerated Approval of Pfizer’s Maraviroc for Treatment-Experienced Patients
April 25	Solvay Pharmaceuticals Files Tedisamil, a New Cardiometabolic Product for the Treatment of Atrial Fibrillation and Atrial Flutter
April 27	Submission of NDA for Istradefylline (KW-6002), an Investigational Anti-Parkinson's Disease Drug
April 27	Merck Receives Non Approvable Letter from FDA for Arcoxia (etoricoxib)

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