New Drug Applications Archive - December 2008
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December 1, 2008
- MedImmune Receives FDA Complete Response Letter on Motavizumab
- Lilly Withdraws Application for Additional U.S. Indication for Cymbalta for Chronic Pain
December 2, 2008
December 3, 2008
- Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia
- Questcor Resubmits Supplemental New Drug Application to FDA for H.P. Acthar Gel for Treatment of Infantile Spasms
- Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia
December 4, 2008
December 5, 2008
- FDA Advisory Committee to Discuss Genzyme's Synvisc-One PMA on Tuesday
- FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
December 8, 2008
- Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration
- Alfacell Provides Onconase NDA Submission Update - Dec 8, 2008
- Amylin, Lilly Update on FDA Review of Byetta (exenatide) Injection Monotherapy Submission
- FDA Advisory Committee Unanimously Recommends Approval of Latisse (Bimatoprost Solution 0.03%) as a Treatment for Hypotrichosis of Eyelashes
- Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify
- Marketing Authorization Application for Lipsovir Now Validated by American and European Regulatory Authorities
December 9, 2008
December 10, 2008
December 11, 2008
- Acusphere Announces Results of FDA Advisory Committee Meeting
- Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy
- Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA
December 12, 2008
- Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia
- Merck Announces FDA Acceptance of Supplemental New Drug Application for Isentress (raltegravir) in Adult Patients Previously Untreated for HIV-1
December 15, 2008
December 16, 2008
- Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo
December 19, 2008
- NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia
- AstraZeneca Submits sNDA for Nexium for the Short-Term Treatment of GERD in Infants 0 to 1 Year Old
- FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application
- King Pharmaceuticals Announces Submission of New Drug Application for CorVue
December 22, 2008
December 23, 2008
December 24, 2008
- AstraZeneca Receives FDA Complete Response Letter on Seroquel XR for Major Depressive Disorder
- Takeda Receives New Action Date for Alogliptin (SYR-322) NDA
December 29, 2008
- Salix Receives FDA Complete Response Letter for Balsalazide Tablet
- FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application
December 30, 2008
- Pegloticase BLA Filing Accepted for Priority Review by FDA
- BLA for PolyHeme Accepted for Filing and Granted Priority Review
- GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy
