New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

July 2009

July 1

Novartis Receives Complete Response Letter From The US Food And Drug Administration For Its Investigational Vaccine Menveo 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 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 Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease 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 Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl) 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 FDA Advisory Committee Votes in Favor of Saphris (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

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