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August 2009
August 4
Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa
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
NeurogesX Announces New PDUFA Date for Qutenza New Drug Application
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
Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting for Onrigin
Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement
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 17
U.S. Food and Drug Administration Approves Protalix's Treatment Protocol for prGCD
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
Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
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.
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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