New Drug Applications Archive for 2008
January 2, 2008
- Cephalon Submits New Drug Application for Treanda for the Treatmentof Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
- Salix Pharmaceuticals Announces Submission of Granulated Mesalamine New Drug Application
- Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
- AstraZeneca Submits sNDAs for Seroquel XR for the Treatment of Bipolar Mania and Bipolar Depression
- Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee
January 3, 2008
- MGI Pharma and Helsinn Announce sNDA for Aloxi Capsules Accepted for Review by U.S. FDA
- Schering-Plough Announces New Drug Application for SugammadexAssigned Priority Review Status by U.S. FDA
January 4, 2008
- TAP Pharmaceutical Products Inc. Files New Drug Application forTAK-390MR in Patients with Acid-Related Disorders
- Takeda Submits New Drug Application for Alogliptin (SYR-322) in theU.S.
- Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration
January 7, 2008
January 8, 2008
- FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues
- Cipher Provides Product Update on Cip-Isotretinoin and Cip-Tramadol ER
January 9, 2008
January 10, 2008
- Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months
- FDA Accepts for Filing the BEMA Fentanyl NDA from BioDelivery Sciences
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting
January 14, 2008
- FDA Extends Review of Genasense NDA Appeal in Chronic Lymphocytic Leukemia
- Inspire Announces Its Termination of Bilastine Licensing Agreement
January 16, 2008
- Ligand Partner Pfizer Submits NDA for Fablyn
- Keppra XR Extended-Release Tablets Filed with the FDA
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima)
January 18, 2008
January 22, 2008
- Cardiome And Astellas Announce Kynapid Regulatory Update
- Hologic Announces Sale of Gestiva
- Xanthus Announces Oral Fludarabine NDA Accepted for Review by U.S. FDA
January 23, 2008
January 24, 2008
- Adolor and GlaxoSmithKline Report Favorable FDA Advisory CommitteeMeeting for Entereg (alvimopan) for the Management of PostoperativeIleus in Bowel Resection
- New Drug Application Submitted to FDA for Investigational AnalgesicTapentadol Immediate Release Tablets
- Labopharm Receives FDA Response to Recent Appeal of ApprovableLetter For Once-Daily Tramadol
January 25, 2008
January 29, 2008
- Pipex Pharmaceuticals Provides Update on Coprexa (OralTetrathiomolybdate) New Drug Application
- Pharming Provides Update on Rhucin
January 30, 2008
January 31, 2008
- Lev Pharmaceuticals Receives Complete Response Letter for Cinryze
- Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport in Cervical Dystonia
- Somaxon Pharmaceuticals Submits New Drug Application for Silenorfor the Treatment of Insomnia
February 1, 2008
- Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application
- Jazz Pharmaceuticals, Inc. Announces Submission of Complete Response to FDA Approvable Letter for Luvox CR
February 4, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
- Luitpold Pharmaceuticals, Inc., Comment on FDA Advisory Committee Meeting to Evaluate Injectafer (Ferric Carboxymaltose Injection)
- MedImmune Submits Biologics License Application to FDA for Motavizumab
February 5, 2008
February 6, 2008
February 11, 2008
February 12, 2008
February 13, 2008
February 19, 2008
- FDA Accepts Treanda New Drug Application for the Treatment ofRelapsed Indolent Non-Hodgkin's Lymphoma
- AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease
February 20, 2008
- Sciele Provides Update on Head Lice Asphyxiation Product
- Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension
- Inclusion of Six-Year Overall Survival Data in the Eloxatin (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
- GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral)
February 21, 2008
- Eurand Granted Priority Review for Zentase NDA
- Forest and Cypress Announce FDA Acceptance for Review of New Drug Application for Milnacipran for the Treatment of Fibromyalgia
February 22, 2008
February 25, 2008
February 27, 2008
- Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol in the Treatment of Postoperative Ocular Inflammation
- FDA Accepts for Review Ovation's Two NDA Submissions for Sabril
February 28, 2008
- Kyowa Hakko Receives Not Approvable Letter from FDA forIstradefylline (KW-6002)
- FDA Issues Not-Approvable Letter for Lilly's Zyprexa Long-Acting Injection for Schizophrenia Treatment
February 29, 2008
- AstraZeneca Submits sNDA for Seroquel XR for the Treatment of Major Depressive Disorder
- Alpharma Submits New Drug Application for Embeda
- PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration
March 3, 2008
- FDA Grants Priority Review for Promacta (eltrombopag)
- FDA Grants Priority Review for Aciphex (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
March 6, 2008
- FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
- CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
March 7, 2008
- Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen
- FDA Extends Review Timeline for Additional Indication forAntibiotic Doribax
March 10, 2008
March 11, 2008
March 12, 2008
- FDA Advisory Committee Unanimously Recommends U.S. Approval ofSugammadex, the First and Only Selective Relaxant Binding Agent
- Amgen to Discuss Romiplostim Application at FDA ODAC Meeting
- Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA
March 13, 2008
- Neurochem Moves Eprodisate (Kiacta) Drug Development Program Forward for Amyloid A Amyloidosis
- Lev Announces FDA's Blood Products Advisory Committee to ReviewCinryze (C1 inhibitor)
- Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
March 17, 2008
- FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
- Ipsen and Medicis Announce Submission of Reloxin BLA in Aesthetics to the FDA
- QLT Announces Positive FDA Action on Aczone
March 18, 2008
March 19, 2008
- Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections
- Supplemental Application for Gardasil, Merck's Cervical Cancer Vaccine, Designated Priority Review by the U.S. FDA for Use in Women 27 through 45
March 20, 2008
March 24, 2008
April 1, 2008
April 4, 2008
April 8, 2008
- Endo Pharmaceuticals Provides Updates on Frova and Chronogesic Clinical Development Programs
- Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis
April 9, 2008
April 10, 2008
April 14, 2008
- Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA
April 15, 2008
- Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema
- Somaxon Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Silenor for the Treatment of Insomnia
April 22, 2008
- Sciele Pharma Announces FDA Acceptance of NDA for Addrenex Pharmaceuticals' CloniBID to Treat Hypertension
- Alpharma to Withdraw and Resubmit Its New Drug Application for Embeda
April 24, 2008
- FDA Issues Not Approvable Letter for Icatibant in the Treatment ofHAE
- Wyeth Withdraws Its Application to Extend the Marketing Authorisation for Tygacil
April 28, 2008
April 29, 2008
- MediQuest Therapeutics Submits New Drug Application to FDA for MQX-503 to treat Raynaud's Disease
- Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
- Acusphere Submits New Drug Application for FDA Approval of Imagify
April 30, 2008
- AstraZeneca Submits an sNDA for Symbicort for COPD Indication
- Spherix D-tagatose to be Supplied by Inalco SpA
May 1, 2008
- Pro-Pharmaceuticals Updates NDA Filing for Davanat
- Amgen to Participate in Dermatologic and Ophthalmic Drugs AdvisoryCommittee Meeting in June
May 2, 2008
- Discovery Labs Receives An Approvable Letter From FDA for Surfaxin for RDS
- Lev Announces FDA Advisory Committee Unanimously RecommendsApproval of Cinryze for Hereditary Angioedema
May 5, 2008
May 6, 2008
- Lev Pharmaceuticals Announces Cinryze Complete Response SubmissionAccepted for Review by FDA
- AstraZeneca Submits sNDA for Seroquel XR for the Treatment of Major Depressive Disorder
May 7, 2008
May 8, 2008
May 9, 2008
May 13, 2008
May 15, 2008
May 16, 2008
May 19, 2008
- Ipsen and Medicis Announce Acceptance of Reloxin BLA in Aesthetics by FDA
- Salix Pharmaceuticals Receives Approvable Letter from FDA for Balsalazide Tablet
May 20, 2008
May 21, 2008
May 27, 2008
May 28, 2008
- The Medicines Company Receives FDA Review Letter for Angiomax Supplemental Filing
- Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing byFDA for the Treatment of Overactive Bladder
May 29, 2008
- Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in Surfaxin Approvable Letter
- GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic/Zunrisa (Casopitant)
- Lilly Submits Cymbalta Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
- Wyeth Receives Approvable Letter from FDA for Tygacil for theTreatment of Patients with Community-Acquired Pneumonia
May 30, 2008
- AstraZeneca Submits sNDA for Nexium I.V. for Peptic Ulcer Bleed Indication
- Novo Nordisk Files for Regulatory Approval of Liraglutide in Both the US and Europe
- Promacta (eltrombopag) Receives Unanimous Recommendation by FDA Advisory Panel
June 2, 2008
June 3, 2008
June 4, 2008
- Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%
- Allergan Announces Intent to File New Drug Application for Bimatoprost as Novel Treatment to Stimulate Natural Eyelash Growth
- Meda: FDA Requests More Information on New Azelastine Formulation
- Indevus Pharmaceuticals Provides Update on Nebido NDA Status
- AstraZeneca Submits an sNDA for Symbicort for the Treatment of Asthma in Children as Young as Age Six
- ThermoGenesis Announces Filing of 510 Application for MarrowXpress
June 6, 2008
June 10, 2008
June 17, 2008
- Cipher's Revised NDA for CIP-Tramadol ER Accepted for Review by FDA
- Genzyme Files Applications for Approval of Mozobil in the United States and Europe
June 18, 2008
- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
- Enbrel (etanercept) Application for the Treatment of Pediatric Psoriasis to be Discussed at FDA Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting
June 19, 2008
- Amgen and Wyeth Statement on Outcome of Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting
- Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase)
- Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter
June 20, 2008
June 23, 2008
- Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for Promacta NDA
- Jerini to Submit Complete Response to the FDA for Icatibant in theTreatment of HAE
June 24, 2008
June 25, 2008
June 26, 2008
- U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia
- FDA Files Application to Convert Ontak (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
June 27, 2008
- Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture
- Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
June 30, 2008
- Labopharm Receives Response from FDA Regarding its Once-DailyTramadol Product
- New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
- Introgen Submits Advexin Regulatory Applications in the U.S. and Europe
- GlaxoSmithKline Responds to FDA on Cervarix and Plans to SubmitFinal Study Data for Approval
- AstraZeneca Submits for New Dosage Strengths of Atacand Plus
- Indevus Receives Approvable Letter from FDA for Nebido
- Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease
July 1, 2008
- Alpharma Announces the Resubmission of a New Drug Application forEmbeda Capsules
- EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist
- ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
- VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid, a Novel Topical Agent for the Treatment of Various Skin Disorders
July 3, 2008
July 7, 2008
July 14, 2008
- FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
July 15, 2008
July 16, 2008
July 17, 2008
July 18, 2008
July 21, 2008
July 22, 2008
- Xanodyne Receives Approvable Letter From the FDA for Zipsor Capsules
- CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin
July 23, 2008
- NexMed Receives FDA Response for Topical ED Product
- Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for Onglyza (saxagliptin) for the Treatment of Type 2 Diabetes
July 24, 2008
July 28, 2008
- CVT Announces That FDA Continues to Review Ranexa Applications
- Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures
- Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
July 29, 2008
- Meda: The FDA has accepted for filing the registration application for Sublinox
- Antares Pharma and Teva Announce Filing of sNDA for Needle-Free Injector with Human Growth Hormone
- UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain
- FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
July 30, 2008
August 1, 2008
August 6, 2008
August 7, 2008
- GTC Biotherapeutics Completes BLA Submission For ATryn
- Othera Files IND Application for OT-730 in Glaucoma
August 8, 2008
- FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months
- Multaq (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
- Meda: Registration Application for Azelastine Extra Strength Submitted to the FDA
August 11, 2008
August 21, 2008
August 27, 2008
August 28, 2008
September 2, 2008
- Alpharma Announces Acceptance of the Embeda Capsule NDA Filing
- Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File
September 3, 2008
- ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer
- Inhaled Treprostinil New Drug Application Filed by FDA
September 8, 2008
September 9, 2008
September 10, 2008
September 15, 2008
- Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer
- Cephalon Receives Complete Response Letter Regarding Request for Expanded Fentora Label for Non-Cancer Breakthrough Pain
- Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
September 16, 2008
September 17, 2008
- Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure
- Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
September 18, 2008
- FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application
September 19, 2008
September 22, 2008
September 23, 2008
- FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma
- Genzyme Announces FDA Priority Review for Mozobil New Drug Application
September 24, 2008
- Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes
- Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema
- Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin
September 26, 2008
September 29, 2008
October 1, 2008
- Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia
- New Drug Application (NDA) for Lipsovir submitted to US FDA
- Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings
October 2, 2008
October 6, 2008
October 9, 2008
October 10, 2008
October 13, 2008
October 14, 2008
October 15, 2008
October 17, 2008
October 20, 2008
- FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR
- AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS
- NexMed Discusses End of Review Meeting for Vitaros
- FDA Defers Final Action on Milnacipran New Drug Application
October 21, 2008
- Intercell making strides towards imminent approval of its Japanese Encephalitis vaccine in the United States –Approvals in United States, Europe and Australia remain on track for 2008
- KV Provides Update on Gestiva PDUFA Date
October 22, 2008
October 24, 2008
October 27, 2008
October 28, 2008
October 29, 2008
- Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme
- Cipher Provides CIP-Tramadol ER Regulatory Update
October 31, 2008
- Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for Fusilev in Colorectal Cancer
- Erbitux Supplemental Biologics License Application for First-Line Recurrent or Metastatic Head and Neck Cancer Accepted for Priority Review by U.S. Food and Drug Administration
- Savient Submits Biologics License Application (BLA) for Pegloticase
November 3, 2008
November 6, 2008
- Debiopharm Submits Response to the FDA for Sanvar (Debio 8609) for Esophageal Variceal Bleeding
- Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal
- Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
November 7, 2008
November 10, 2008
- GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome
- FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin
November 13, 2008
November 14, 2008
- ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve
- Watson Announces the NDA for a 6-Month Formulation of Trelstar Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer
November 17, 2008
November 18, 2008
November 20, 2008
- FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
- Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
- Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
- Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA
November 21, 2008
- Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
- FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema
November 24, 2008
- Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA
- FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months
- Genzyme Seeks U.S. Approval for Clolar to Treat Adult AML
November 25, 2008
November 26, 2008
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
December 31, 2008
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