New Drug Applications Archive

New Drug Applications: August 2009

August 4	Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa
August 4	Kamada's Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administration
August 5	FDA Extends Review of Pennsaid Diclofenac Sodium Topical Solution
August 6	Abstral NDA submitted to the FDA for approval in the USA
August 6	NeurogesX Announces New PDUFA Date for Qutenza New Drug Application
August 6	Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza (Cethromycin) in Community Acquired Pneumonia
August 7	Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
August 11	Allos Therapeutics Announces FDA Advisory Committee to Review Pralatrexate for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
August 12	Wyeth Provides Regulatory Update on Prevnar 13 in the United States
August 12	Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting for Onrigin
August 12	Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement
August 12	U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application for tesamorelin
August 14	Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
August 18	Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application
August 19	BioAlliance Pharma: FDA Accepts Drug Application for Miconazole Lauriad (Loramyc) to Treat Oropharyngeal Candidiasis
August 25	FDA Issues Complete Response Letter for Carisbamate
August 25	Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
August 25	Salix Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review Designation For Rifaximin NDA For the Maintenance of Remission of Hepatic Encephalopathy
August 26	Endo Pharmaceuticals to Partner With ProStrakan to Commercialize Fortesta in the U.S.
August 26	FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone
August 28	Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes

New Drug Applications Archive

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