New Drug Applications Archive

New Drug Applications: July 2009

July 1	Novartis Receives Complete Response Letter From The US Food And Drug Administration For Its Investigational Vaccine Menveo
July 1	Photocure submits application for marketing approval for Hexvix in USA to the FDA
July 2	Discovery Labs Reports On Surfaxin End of Review Meeting With FDA
July 2	Acura and King Receive FDA Complete Response Letter Regarding Acurox
July 7	Somaxon Announces $6 Million Private Equity Financing and Acceptance of NDA Resubmission of Silenor for the Treatment of Insomnia
July 7	Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
July 7	New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
July 8	Bayer submits first-in-class estradiol-based oral contraceptive for approval in the U.S.
July 14	Protalix Holds Pre-NDA Meeting with FDA for prGCD
July 15	Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever
July 16	New Drug Application for Rivaroxaban in the U.S.
July 20	A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting
July 22	Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product
July 23	Nycomed Announces FDA Filing for Daxas in COPD
July 23	Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl)
July 23	Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
July 28	FDA Issues Complete Response Letter for Intuniv (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
July 30	AstraZeneca Submits New Drug Applications for Zactima in Second-Line Advanced Non-Small Cell Lung Cancer
July 30	FDA Advisory Committee Votes in Favor of Saphris (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

New Drug Applications Archive

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