New Drug Applications Archive for 2009

January 2, 2009

• New Drug Application Submitted For Acurox Tablets

January 5, 2009

• UCB Receives Complete Response Letter from U.S. FDA for Use of Cimzia in Rheumatoid Arthritis Patients

January 8, 2009

• FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults

January 9, 2009

• FDA Advisory Committee Unanimously Recommends Sabril (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
• GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome
• Merck & Co., Inc. Receives Complete Response Letter from the Food and Drug Administration for Use of Gardasil in Women Ages 27 through 45

January 12, 2009

• FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn (antithrombin [Recombinant])

January 13, 2009

• Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema

January 14, 2009

• FDA Issues Complete Response Letter for Saphris for Acute Treatment of Both Schizophrenia and Bipolar I Disorder

January 15, 2009

• ISTA Pharmaceuticals' New Drug Application for Bepreve Accepted for Review by U.S. Food and Drug Administration
• Osiris and FDA Reach Agreement on Submission of First Marketing Application for a Stem Cell Product

January 20, 2009

• FDA Issues Complete Response Letter for Iclaprim
• Pfizer Receives FDA Complete Response Letter for Lasofoxifene
• Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date

January 26, 2009

• ImClone Systems and Bristol-Myers Squibb Update the Status of Non-Small Cell Lung Cancer sBLA Submission for Erbitux
• KV Pharmaceutical's Launch of Gestiva Delayed
• Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes

January 27, 2009

• Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia

January 28, 2009

• Alfacell Provides Onconase NDA Submission Update - Jan 28, 2009
• Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients

January 30, 2009

• GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

February 2, 2009

• Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
• EpiCept Receives Permission to File Ceplene NDA

February 4, 2009

• Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee

February 5, 2009

• FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema
• Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for Intelence (etravirine)

February 6, 2009

• Roxro Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
• UCB's meeting with U.S. FDA defines path forward for Cimzia in rheumatoid arthritis
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega

February 11, 2009

• FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder

February 12, 2009

• Savient Provides Update on Pegloticase BLA

February 17, 2009

• Vion Pharmaceuticals Submits New Drug Application for Onrigin

February 18, 2009

• GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA
• Zogenix Reports FDA Provides New PDUFA Date for Sumavel DosePro
• FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
• Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments

February 19, 2009

• FDA Accepts Nuvo's Resubmission For Pennsaid
• Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution

February 20, 2009

• Schering-Plough Submits Response to FDA for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

February 27, 2009

• Somaxon Receives Complete Response Letter from the FDA for Silenor (doxepin)
• Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI
• AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder
• Salix Announces FDA Complete Response Letter for Metozolv ODT
• Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee

March 2, 2009

• US Food and Drug Administration Issues Complete Response Letter Regarding the Tracleer Supplemental New Drug Application
• ImClone Systems and Bristol-Myers Squibb Update Status of First-Line Squamous Cell Carcinoma of the Head and Neck Supplemental Biologics Application for Erbitux in U.S.
• Pharmaxis Announces New Drug Application Submission for Aridol

March 3, 2009

• Genzyme Receives Complete Response Letter from FDA on Lumizyme Application
• Acurox Tablets New Drug Application Accepted for Filing With a Priority Review Classification

March 5, 2009

• FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA

March 6, 2009

• Takeda Receives New Information on Alogliptin (SYR-322) NDA

March 9, 2009

• FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
• Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

March 12, 2009

• FDA Accepts Complete Response Submission to New Drug Application for Nebido

March 16, 2009

• XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA
• United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
• Sirion Therapeutics Supplemental New Drug Application for Durezol to Treat Uveitis is Accepted for Review by the FDA
• Zenvia Phase III PBA Trial Completes Patient Enrollment
• MannKind Submits NDA for Afresa for Treatment of Diabetes

March 18, 2009

• Questcor Submits Supplemental New Drug Application to FDA for H.P. Acthar Gel for Treatment of Infantile Spasms

March 19, 2009

• FDA Advisory Committee Recommends Approval of Multaq (dronedarone)
• OSI Pharmaceuticals Submits sNDA  for Tarceva as a First-Line Maintenance Therapy in Advanced NSCLC

March 20, 2009

• FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery

March 25, 2009

• Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

March 26, 2009

• Spectrum Pharmaceuticals Announces That FDA Has Accepted Fusilev sNDA for Colorectal Cancer Indication

March 27, 2009

• Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema

March 30, 2009

• Cervarix U.S. Regulatory Update

March 31, 2009

• Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy
• Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
• Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers
• FDA Advisory Committee Unanimously Recommends Accelerated Approval of Avastin for Previously Treated Brain Cancer (Glioblastoma)

April 2, 2009

• Onglyza (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee
• GSK Submits Tyverb/Tykerb (lapatinib) for First-line Treatment of Metastatic Breast Cancer in Europe, US
• Xanodyne's New Drug Application for XP12B the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification

April 3, 2009

• Arzerra (Ofatumumab) Granted Priority Review By FDA
• Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes

April 6, 2009

• Santarus Announces FDA Acceptance of New Drug Application for Zegerid Tablet Product

April 7, 2009

• Theravance Announces FDA Acceptance of Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia
• AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old
• Somaxon Provides Update on New Drug Application for Silenor (doxepin) for the Treatment of Insomnia

April 8, 2009

• FDA Advisory Committee provides opinion on Serdolect for the treatment of schizophrenia

April 9, 2009

• Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet
• MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
• FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications

April 14, 2009

• Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone

April 16, 2009

• Vion Pharmaceuticals' New Drug Application for Onrigin Accepted For Review by the FDA

April 23, 2009

• U.S. Food and Drug Administration Extends Review Timeline for Onglyza (saxagliptin) New Drug Application
• Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
• Vion Pharmaceuticals Receives a Standard Review from the FDA for Its New Drug Application for Onrigin

April 25, 2009

• FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections

April 28, 2009

• U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months

April 29, 2009

• BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for Xiaflex for the Treatment of Dupuytren's Disease

May 1, 2009

• Northfield Receives Complete Response Letter for PolyHeme BLA

May 4, 2009

• AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
• FDA Advisory Committee to Review Arzerra (Ofatumumab)

May 5, 2009

• Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes

May 6, 2009

• Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing

May 7, 2009

• Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout
• Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009

May 12, 2009

• Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review
• Discovery Labs and FDA to Meet On June 2, 2009 to Discuss Surfaxin Complete Response Letter
• AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection)

May 13, 2009

• Pozen Receives Decision from AstraZeneca to File PN 400 NDA
• Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

May 18, 2009

• A.P. Pharma Submits New Drug Application for APF530 in Chemotherapy-Induced Nausea and Vomiting

May 20, 2009

• Genentech and Biogen Idec Submit Applications to the FDA for Rituxan for Most Common Type of Adult Leukemia
• Lundbeck provides update on NDA for Serdolect for the treatment of schizophrenia

May 21, 2009

• Emisphere Technologies Receives Milestone Payment from MannKind Corporation
• Human Genome Sciences Submits Biologics License Application to FDA for ABthrax
• Genzyme Submits All Information Requested by FDA for Lumizyme

May 22, 2009

• Skyepharma plc: Flutiform NDA Accepted for Review

May 26, 2009

• PharmAthene Submits SparVax Regulatory Strategy to FDA

May 27, 2009

• Allergan Receives Complete Response Letter for Botox (Botulinum Toxin Type A) for Treatment of Upper Limb Spasticity in Adults
• FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months
• Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive

May 28, 2009

• U.S. FDA Issues Complete Response Letter for Rivaroxaban

May 29, 2009

• Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin)
• GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel

June 1, 2009

• Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA
• ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA

June 2, 2009

• ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
• Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency
• GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review

June 3, 2009

• Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin)
• Lilly Resubmits Cymbalta Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
• Public Citizen: Antiplatelet Medication Is Unsafe, Should Not Be Approved,Says Scientist Who Helped Develop the Drug
• Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration

June 4, 2009

• Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia
• ViroPharma Receives Complete Response Letter for Cinryze Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

June 5, 2009

• Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia
• Paclitaxel Poliglumex (OPAXIO Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer

June 8, 2009

• Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema

June 9, 2009

• Santarus Announces Schering-Plough Response Submission to FDA for OTC Zegerid

June 10, 2009

• SkyePharma Inc. Says FDA May Need More Flutiform Data
• NeurogesX Provides U.S. Regulatory Update for Qutenza

June 11, 2009

• Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo
• Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA

June 12, 2009

• FDA Accepts Final Section of NDA Filing for Lucassin

June 15, 2009

• BioDelivery Sciences Provides NDA Update for Onsolis
• OSI Pharmaceuticals Announces Acceptance of Tarceva Supplemental New Drug Application for Review by the U.S. Food and Drug Administration

June 16, 2009

• FDA Extends Review of Arzerra (ofatumumab)
• Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws

June 17, 2009

• FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout

June 24, 2009

• Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review

June 28, 2009

• Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
• Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

June 30, 2009

• Pozen Submits New Drug Application For Vimovo (PN 400)
• Cephalon Submits Nuvigil Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

July 1, 2009

• Novartis Receives Complete Response Letter From The US Food And Drug Administration For Its Investigational Vaccine Menveo
• Photocure submits application for marketing approval for Hexvix in USA to the FDA

July 2, 2009

• Discovery Labs Reports On Surfaxin End of Review Meeting With FDA
• Acura and King Receive FDA Complete Response Letter Regarding Acurox

July 7, 2009

• Somaxon Announces $6 Million Private Equity Financing and Acceptance of NDA Resubmission of Silenor for the Treatment of Insomnia
• Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
• New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

July 8, 2009

• Bayer submits first-in-class estradiol-based oral contraceptive for approval in the U.S.

July 14, 2009

• Protalix Holds Pre-NDA Meeting with FDA for prGCD

July 15, 2009

• Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever

July 16, 2009

• New Drug Application for Rivaroxaban in the U.S.

July 20, 2009

• A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting

July 22, 2009

• Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product

July 23, 2009

• Nycomed Announces FDA Filing for Daxas in COPD
• Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl)
• Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

July 28, 2009

• FDA Issues Complete Response Letter for Intuniv (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

July 30, 2009

• AstraZeneca Submits New Drug Applications for Zactima in Second-Line Advanced Non-Small Cell Lung Cancer
• FDA Advisory Committee Votes in Favor of Saphris (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

August 4, 2009

• 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, 2009

• FDA Extends Review of Pennsaid Diclofenac Sodium Topical Solution

August 6, 2009

• 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
• Opaxio Combined with Alimta Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer

August 7, 2009

• Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA

August 11, 2009

• Allos Therapeutics Announces FDA Advisory Committee to Review Pralatrexate for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

August 12, 2009

• 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, 2009

• Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting

August 17, 2009

• U.S. Food and Drug Administration Approves Protalix's Treatment Protocol for prGCD

August 18, 2009

• Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application

August 19, 2009

• BioAlliance Pharma: FDA Accepts Drug Application for Miconazole Lauriad (Loramyc) to Treat Oropharyngeal Candidiasis

August 25, 2009

• Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
• FDA Issues Complete Response Letter for Carisbamate
• Salix Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review Designation For Rifaximin NDA For the Maintenance of Remission of Hepatic Encephalopathy

August 26, 2009

• 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, 2009

• Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes

September 1, 2009

• Pozen Announces FDA Acceptance of NDA For Vimovo
• Photocure ASA (NO) - Hexvix has been granted priority review by the FDA

September 2, 2009

• Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin
• Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
• FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma

September 3, 2009

• FDA accepts for review the Complete Response submission to ceftobiprole NDA
• Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism
• Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of Folotyn (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
• Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application
• Acura Pharmaceuticals and King Pharmaceuticals Provide Update on Acurox NDA

September 4, 2009

• Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes

September 6, 2009

• FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA

September 7, 2009

• Archimedes Announces US Filing of NasalFent for the treatment of Breakthrough Cancer Pain

September 9, 2009

• ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA
• FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine

September 10, 2009

• FDA Advisory Committee Recommends Approval for Use of Gardasil ln Boys and Men
• FDA Issues Complete Response Letter For Trabectedin Combined With Doxil

September 11, 2009

• Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA
• Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval

September 17, 2009

• FDA Advisory Committee Unanimously Recommends Approval of Xiaflex for Treatment of Dupuytren's Disease
• Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission

September 18, 2009

• FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for Velcade (bortezomib) for Injection

September 19, 2009

• Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa

September 23, 2009

• FDA Advisory Committee Hears Presentations and Public Comment on Exalgo Extended-Release Tablets

September 25, 2009

• NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA

September 28, 2009

• GSK Provides Update on Regulatory Filings for Zunrisa/Rezonic

September 29, 2009

• Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

October 2, 2009

• Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD
• Discovery Labs and FDA Establish Path for Potential Surfaxin Approval
• Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

October 3, 2009

• OPAXIO Produces High Rates of Pathologic Complete Remission in Patients with Advanced Esophageal Cancer; Study Paves Way for Potential Registration Trial as Radiation Sensitizer

October 5, 2009

• GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for Votrient

October 6, 2009

• Orexo confirms FDA acceptance of Abstral filing

October 12, 2009

• Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles

October 14, 2009

• Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR

October 21, 2009

• FDA Issues Complete Response Letter for CorVue
• Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)

October 22, 2009

• Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
• Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta

October 23, 2009

• Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD

October 26, 2009

• Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009

October 30, 2009

• Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application

November 2, 2009

• Dendreon Completes Submission of Biologics License Application for Provenge
• GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application

November 4, 2009

• FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
• InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF

November 5, 2009

• Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee

November 10, 2009

• ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status

November 13, 2009

• Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months

November 16, 2009

• Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application
• Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets

November 17, 2009

• Genzyme Receives Complete Response Letter on Lumizyme Application

November 18, 2009

• NicOx announces FDA accepts naproxcinod NDA for filing

November 19, 2009

• AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent

November 22, 2009

• Dendreon Receives FDA Acknowledgement of Complete Response for Provenge

November 23, 2009

• FDA has posted an Advisory Committee meeting with Photocure to discuss Hexvix NDA

November 24, 2009

• Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter

November 25, 2009

• Human Genome Sciences Submits Biologics License Application to FDA for Zalbin

November 30, 2009

• Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application

December 2, 2009

• Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults
• Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia

December 3, 2009

• Endo Pharmaceuticals Provides Regulatory Update on Aveed (Testosterone Undecanoate) Injection

December 7, 2009

• Somaxon Receives Complete Response Letter from the FDA for Silenor NDA
• Genzyme to Reopen Enrollment in Alglucosidase Alfa Temporary Access Program

December 8, 2009

• BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment

December 10, 2009

• Protalix Completes NDA Submission for taliglucerase alfa for the Treatment of Gaucher's Disease

December 11, 2009

• FDA Advisory Committee Supports Use of Aztreonam for Inhalation Solution for Patients With Cystic Fibrosis

December 14, 2009

• Vion Pharmaceuticals Receives Complete Response Letter for Onrigin From The U.S. Food And Drug Administration

December 15, 2009

• Jazz Pharmaceuticals Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
• Alexza Announces Submission of AZ-004 (Staccato Loxapine) NDA

December 17, 2009

• Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
• ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation

December 18, 2009

• Somaxon Scheduled to Meet with FDA to Discuss Complete Response Letter for Silenor NDA

December 22, 2009

• Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management
• Shire Submits Biologics License Application for Replagal With the U.S. Food and Drug Administration
• Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles

December 23, 2009

• ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Once-Daily XiDay

December 29, 2009

• Vivus Submits Qnexa New Drug Application to the FDA for the Treatment of Obesity

December 30, 2009

• FDA Issues Complete Response Letter for Ceftobiprole
• FDA Accepts NDA Filing for Retigabine