New Drug Applications Archive

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June 2009

June 1

Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA

June 2

ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review

June 3

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin) Lilly Resubmits Cymbalta Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration Public Citizen: Antiplatelet Medication Is Unsafe, Should Not Be Approved,Says Scientist Who Helped Develop the Drug Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration

June 4

Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia ViroPharma Receives Complete Response Letter for Cinryze Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

June 5

Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia

June 8

Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema

June 9

Santarus Announces Schering-Plough Response Submission to FDA for OTC Zegerid

June 10

SkyePharma PLC - Flutiform U.S. Filing Update NeurogesX Provides U.S. Regulatory Update for Qutenza

June 11

Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA

June 12

FDA Accepts Final Section of NDA Filing for Lucassin

June 15

BioDelivery Sciences Provides NDA Update for Onsolis OSI Pharmaceuticals Announces Acceptance of Tarceva Supplemental New Drug Application for Review by the U.S. Food and Drug Administration

June 16

FDA Extends Review of Arzerra (ofatumumab) Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws

June 17

FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout

June 24

Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review

June 28

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

June 30

Pozen Submits New Drug Application For Vimovo (PN 400) Cephalon Submits Nuvigil Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

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