New Drug Applications Archive

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December 2008

December 1

MedImmune Receives FDA Complete Response Letter on Motavizumab 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 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

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 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 Alfacell Provides Onconase NDA Submission Update - Dec 8, 2008 FDA Advisory Committee Unanimously Recommends Approval of Latisse (Bimatoprost Solution 0.03%) as a Treatment for Hypotrichosis of Eyelashes Amylin, Lilly Update on FDA Review of Byetta (exenatide) Injection Monotherapy Submission 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

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 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

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

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 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

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 Takeda Receives New Action Date for Alogliptin (SYR-322) NDA

December 29

Salix Receives FDA Complete Response Letter for Balsalazide Tablet FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application

December 30

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

December 31

King Pharmaceuticals Provides Update on Embeda NDA Review FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel

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