New Drug Applications Archive

New Drug Applications: December 2008

December 1	MedImmune Receives FDA Complete Response Letter on Motavizumab
December 1	Lilly Withdraws Application for Additional U.S. Indication for Cymbalta for Chronic Pain
December 2	ViroPharma Submits Supplemental Biologics License Application for Cinryze to Treat Acute Attacks of Hereditary Angioedema
December 3	Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia
December 3	Questcor Resubmits Supplemental New Drug Application to FDA for H.P. Acthar Gel for Treatment of Infantile Spasms
December 3	Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia
December 4	Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)
December 5	FDA Advisory Committee to Discuss Genzyme's Synvisc-One PMA on Tuesday
December 5	FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
December 8	Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration
December 8	FDA Advisory Committee Unanimously Recommends Approval of Latisse (Bimatoprost Solution 0.03%) as a Treatment for Hypotrichosis of Eyelashes
December 8	Alfacell Provides Onconase NDA Submission Update
December 8	Amylin, Lilly Update on FDA Review of Byetta (exenatide) Injection Monotherapy Submission
December 8	Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify
December 8	Marketing Authorization Application for Lipsovir Now Validated by American and European Regulatory Authorities
December 9	FDA Issues Complete Response Letter for Oritavancin
December 10	FDA Advisory Committee Unanimously Recommends Approval of Genzyme's Synvisc-One
December 11	Acusphere Announces Results of FDA Advisory Committee Meeting
December 11	Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy
December 11	Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA
December 12	Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia
December 12	Merck Announces FDA Acceptance of Supplemental New Drug Application for Isentress (raltegravir) in Adult Patients Previously Untreated for HIV-1
December 15	BioDelivery Sciences Submits REMS for Onsolis to FDA for Approval
December 16	Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo
December 19	NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia
December 19	AstraZeneca Submits sNDA for Nexium for the Short-Term Treatment of GERD in Infants 0 to 1 Year Old
December 19	FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application
December 19	King Pharmaceuticals Announces Submission of New Drug Application for CorVue
December 22	Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer
December 23	AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol
December 24	AstraZeneca Receives FDA Complete Response Letter on Seroquel XR for Major Depressive Disorder
December 24	Takeda Receives New Action Date for Alogliptin (SYR-322) NDA
December 29	Salix Receives FDA Complete Response Letter for Balsalazide Tablet
December 29	FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application
December 30	Pegloticase BLA Filing Accepted for Priority Review by FDA
December 30	BLA for PolyHeme Accepted for Filing and Granted Priority Review
December 30	GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy
December 31	King Pharmaceuticals Provides Update on Embeda NDA Review
December 31	FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel

New Drug Applications Archive

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