New Drug Applications Archive for 2007

January 15, 2007

• FDA Accepts for Filing a New Drug Application (NDA) for Somatuline Autogel

January 16, 2007

• Dendreon’s Provenge Granted FDA Priority Review

January 18, 2007

• IMPAX Files Amendment to Vadova NDA

January 22, 2007

• Discovery Labs and FDA Reach Clarity On Path Towards Surfaxin RDS Approval

January 23, 2007

• Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder

January 25, 2007

• FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine

February 6, 2007

• Genta Announces the Company Will Appeal FDA Action on New Drug Application of Genasense in Chronic Lymphocytic Leukemia

February 7, 2007

• Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children
• Pro-Pharmaceuticals' Begins Process of New Drug Application Submission with the FDA for Co-administration of Davanat with 5-FU in Cancer Patients

February 9, 2007

• Nuvo Announces Update on Discussions With FDA Related to Approval of Pennsaid

February 12, 2007

• Rimonabant USA: Update - Feb 12, 2007

February 13, 2007

• Pfizer's Maraviroc to Receive Accelerated Regulatory Reviews in the U.S. and Europe

February 15, 2007

• FDA Accepts ZymoGenetics' Recombinant Human Thrombin Application for Review

February 16, 2007

• Gilead's New Drug Application for Ambrisentan Receives Priority Review Status
• GPC Biotech Submits NDA for Lead Oncology Drug Candidate Satraplatin

February 19, 2007

• Cardiome And Astellas Announce Acceptance Of NDA For Review

February 21, 2007

• Pharmacyclics Receives Refuse to File Letter for Xcytrin

February 26, 2007

• Novartis Committed to Making Galvus Available for Patients with Type 2 Diabetes After US Regulators Issue ''Approvable Letter''

February 27, 2007

• AVANIR Pharmaceuticals Announces Conference Call to Provide Zenvia FDA Meeting Update

February 28, 2007

• Epix Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research

March 1, 2007

• Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer

March 7, 2007

• Nuvo announces further update on discussions with the FDA related to review of Pennsaid

March 12, 2007

• Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone

March 14, 2007

• Adams Respiratory Therapeutics' NDA Submission for Prescription Cough Suppressant Accepted by FDA

March 22, 2007

• Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA

March 23, 2007

• UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US

March 24, 2007

• Advancis Pharmaceutical Resubmits New Drug Application forOnce-Daily Amoxicillin PULSYS

March 26, 2007

• Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant
• Rimonabant USA: Update - Mar 26, 2007

March 27, 2007

• Dendreon to Hold Post Advisory Committee Conference Call for Provenge
• Roche Submits Application to the FDA for use of Xelox (Xeloda plusoxaliplatin) With or Without Avastin for the Treatment of AdvancedColorectal Cancer

March 29, 2007

• GlaxoSmithKline Submits Biologics License Application to U.S. Foodand Drug Administration for Cervarix

March 30, 2007

• Progenics and Wyeth Announce Submission of New Drug Application for the Subcutaneous Formulation of Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care
• Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer

March 31, 2007

• GlaxoSmithKline Files Meningococcal Conjugate Vaccine

April 2, 2007

• EPIX Provides Update Regarding Status of Vasovist Appeal
• Cephalon Provides Update Related to Nuvigil New Drug Application

April 3, 2007

• IDM Pharma Inc. Announces Oncologic Drugs Advisory Committee Meeting for Junovan (Mifamurtide) Will Take Place on May 9, 2007
• CSL Biotherapies Submits BLA to Introduce Flu Vaccine to U.S. Market

April 4, 2007

• Genta Appeals FDA Decision on Genasense in CLL

April 6, 2007

• Wyeth Provides Update on FDA Review of the Torisel New Drug Application

April 9, 2007

• Arthritis Foundation Chief Public Health Officer Testifies at FDA Hearing on Arcoxia

April 10, 2007

• Endo Comments on Notices Received From Anesiva Regarding Zingo

April 11, 2007

• Neurochem's Eprodisate (Kiacta) PDUFA Date Extended Three Months by FDA
• Statement by Merck & Co., Inc. Regarding FDA Arthritis Drugs Advisory Committee Meeting on Arcoxia (etoricoxib)
• Pro-Pharmaceuticals Receives Letter from the FDA for New DrugApplication for Davanat/ 5-FU

April 12, 2007

• FDA Advisory Committee Recommends Against Approval for Merck's NDAfor Arcoxia (etoricoxib)

April 13, 2007

• Skyepharma PLC - Once-Daily Requip (ropinirole HCl) XL 24-Hour Extended-Release Tablets Accepted for Filing by U.S. FDA
• Public Citizen: FDA Should Not Approve "Offspring of Vioxx" Painkiller

April 16, 2007

• FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status

April 17, 2007

• Lung Cancer Alliance Hails FDA Decision to Expedite Review of Xyotax Treatment for Lung Cancer

April 20, 2007

• Abbott Submits New Drug Application for Simcor Combination Niaspan/Simvastatin Tablet

April 23, 2007

• Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin Injection to Treat Lung Cancer Brain Metastases

April 24, 2007

• Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis - May 1, 2007

April 25, 2007

• FDA Advisory Committee Recommends Accelerated Approval of Pfizer’s Maraviroc for Treatment-Experienced Patients
• Solvay Pharmaceuticals Files Tedisamil, a New CardiometabolicProduct for the Treatment of Atrial Fibrillation and Atrial Flutter

April 27, 2007

• Submission of NDA for Istradefylline (KW-6002), an Investigational Anti-Parkinson's Disease Drug
• Merck Receives Non Approvable Letter from FDA for Arcoxia(etoricoxib)

May 1, 2007

• Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol

May 4, 2007

• ISTA Provides Regulatory Update on T-Pred NDA Filing

May 7, 2007

• MGI Pharma and Helsinn Announce Submission of Supplemental New DrugApplication for Aloxi Injection in Post-Operative Nausea andVomiting
• Abbott Seeks U.S. and E.U. Regulatory Approvals for Humira(Adalimumab) as a Treatment for Juvenile Rheumatoid Arthritis

May 8, 2007

• Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment ofMajor Depressive Disorder

May 9, 2007

• Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application
• Somaxon Pharmaceuticals Provides Update on Silenor Development Program
• FDA Advisory Committee Reviews Data on IDM Pharma's Junovan (mifamurtide) for Treatment of Osteosarcoma

May 14, 2007

• Merck Receives Approvable Letter from FDA for Emend (fosaprepitantdimeglumine) For Injection
• Luitpold Pharmaceuticals, Inc., Announces NDA Submission forInjectafer (Ferric Carboxymaltose Injection), a Next GenerationIntravenous Iron Product
• Questcor Receives FDA Action Letter for H.P. Acthar Gel forTreatment of Infantile Spasms

May 15, 2007

• Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer

May 16, 2007

• New Free White Paper Addresses Challenges of New FDA RegulationsAwaiting Combo Product Manufacturers
• FDA Advisory Committee Recommends Expanded Use of FluMist

May 18, 2007

• FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine
• New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole

May 21, 2007

• Roche Receives Approvable Letter for Mircera in the United States
• FDA Issues Approvable Letter for SPD465 (Triple-Bead MixedAmphetamine Salts) for the Treatment of ADHD in Adults
• Single-Tablet Combination of Tekturna and Diuretic, an Important New Option for People With High Blood Pressure, Accepted for Review in U.S.

May 22, 2007

• Advancis Pharmaceutical Announces FDA Acceptance of AmoxicillinPULSYS NDA

May 24, 2007

• BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)

May 29, 2007

• MedImmune Receives Correspondence From FDA Regarding FluMist
• QLT USA, Inc. files Aczone labeling supplement for removal of blood screening requirement

May 30, 2007

• Banner Pharmacaps Inc. and JDS Pharmaceuticals LLC Announce License and Supply Agreement

May 31, 2007

• Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone
• Dendreon Announces FDA Confirms Data Required for Provenge Licensure
• TopoTarget elaborates on the specific initiatives to obtain FDA approval of Totect

June 1, 2007

• Labopharm Receives Second Approvable Letter from FDA for Once-DailyTramadol
• Abbott Submits XIENCE V Everolimus Eluting Coronary Stent System Application for U.S. FDA Approval
• Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge

June 5, 2007

• Abilify (aripiprazole) Supplemental New Drug Application forPediatric Patients With Schizophrenia Accepted for Priority Reviewby the U.S. Food and Drug Administration
• Avalere Health Compares FDA Review of Several Categories of Drugs Including Alzheimer's Disease
• Biovest to File for Accelerated Conditional Approval of BiovaxID

June 6, 2007

• Nuvo Continues Discussions with the FDA Related to Pennsaid
• New Drug Application Submitted for Investigational AntibioticDoripenem

June 8, 2007

• Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS

June 11, 2007

• Pro-Pharmaceuticals Submits Data to Begin a 505 (b)(2) Filing withthe FDA for a New Formulation of Irinotecan to be Co-administeredwith Davanat as a Functional Excipient
• GSK and Adolor Update Alvimopan (Entereg/Entrareg) DevelopmentProgram
• FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer

June 12, 2007

• Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency
• FDA Grants Priority Review for Oral Formulation of Hycamtin(topotecan) to Treat Relapsed Small Cell Lung Cancer

June 13, 2007

• FDA Advisory Committee Did Not Recommend Approval of Rimonabant (Zimulti) for Use in Obese and Overweight Patients With Associated Risks Factors
• Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules

June 14, 2007

• Weight Loss Drug Rimonabant Can Cause Serious Physical andPsychological Harm and Birth Defects, Public Citizen Tells FDA
• Solvay Pharmaceuticals, Inc. Announces Submission of SupplementalNew Drug Application for AndroGel in Male Adolescents

June 18, 2007

• FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)

June 19, 2007

• FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
• Nuvo Provides Update on Discussions with the FDA Related toPennsaid Approval

June 20, 2007

• Inspire and FAES Farma Amend Bilastine Licensing Agreement
• Genzyme Files for Approval of Single-Treatment Synvisc-One

June 21, 2007

• Shire Receives Approvable Letter From FDA for Intuniv (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
• Merck Provides Update on Status of Supplemental Biologics License Applications for Gardasil
• Pfizer Receives Approvable Letter From FDA For Maraviroc
• FDA Issues Approvable Letter for Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania

June 27, 2007

• Bayer and Onyx Submit Supplemental New Drug Application for Nexavarto Treat Liver Cancer
• AVANT's Partner, GlaxoSmithKline, Files Rotarix Application forU.S. Marketing Approval with the FDA
• Taxotere (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Prior to Chemoradiotherapy and Surgery
• FDA Priority Review Granted for Isentress (raltegravir), Merck's Investigational Integrase Inhibitor for HIV

June 28, 2007

• Cephalon Announces Plans for New NDA Filing for Treanda
• Photocure Submits Metvixia NDA to FDA

June 29, 2007

• Labopharm Meets with FDA to Discuss Second Approvable Letter forOnce-daily Tramadol
• Akorn, Inc. Announces the New Drug Application Filing for Akten
• Rimonabant Regulatory Update in the United States
• Shire Announces Filing of Vyvanse (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults

July 2, 2007

• Warner Chilcott and LEO Pharma Announce NDA Submission for Taclonex Scalp Gel
• Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation
• Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin

July 6, 2007

• Wyeth to File for FDA Approval of Tygacil for the Treatment of Patients with Community-Acquired Pneumonia

July 9, 2007

• MGI Pharma and Helsinn Announce Aloxi sNDA for PONV Accepted for Review By U.S. FDA

July 12, 2007

• Sucampo Pharmaceuticals Submits Supplemental New Drug Applicationfor Lubiprostone to Treat Irritable Bowel Syndrome WithConstipation

July 13, 2007

• Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium)

July 17, 2007

• Salix Pharmaceuticals Announces Submission of Balsalazide Tablet New Drug Application

July 18, 2007

• Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
• Abilify (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder
• U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin
• New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration

July 19, 2007

• DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA ActionDate for orBec New Drug Application to Review Supplemental Data
• Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti

July 20, 2007

• Abbott Submits E.U. and U.S. Regulatory Filings for NewLower-Strength Kaletra and Aluvia (lopinavir/ritonavir) TabletSuitable for Pediatric Use in HIV/AIDS
• Biovail Provides Update on BVF-033

July 23, 2007

• IDM Pharma Announces Plans to Amend New Drug Application forMifamurtide (L-MTP-PE) for the Treatment of Patients withOsteosarcoma
• QLT Announces FDA Filing and Review of Aczone Labeling Supplementfor Removal of Blood Screening Requirement

July 24, 2007

• Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause

July 25, 2007

• A.T.S. Pharmaceuticals, A division of Auriga Laboratories Launches Xyralid LP Lotion
• New Study Confirms Link Between Breast Cancer and Hormone Therapy
• Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer

July 26, 2007

• Kuvan Receives Priority Review Status from FDA

July 30, 2007

• GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
• D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame

July 31, 2007

• Lev Pharmaceuticals Submits Biologics License Application forCinryze

August 1, 2007

• Joint FDA Advisory Committee Recommends Approval of Tysabri for the Treatment of Moderate to Severe Crohn's Disease
• Par Pharmaceutical Licenses North American Rights to Zensana from Hana Biosciences

August 2, 2007

• FDA Issues Second Approvable Letter for Trexima
• Discovery Labs Provides Update On Progress for Surfaxin for RDS

August 3, 2007

• Jazz Pharmaceuticals, Inc. Announces Submission of Complete Responses to FDA Approvable Letters for Luvox CR and Luvox

August 6, 2007

• SkyePharma PLC - Flutiform Progress Update

August 7, 2007

• The Medicines Company Submits Angiomax (Bivalirudin) sNDA to Expand Label to Include Acuity Data
• Orenica (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
• Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA to Contest Third Approvable Letter for Thelin

August 8, 2007

• Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
• GSK Receives Decision From FDA on Advair 500/50 for COPD

August 10, 2007

• Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an InvestigationalTreatment for Schizophrenia

August 14, 2007

• GlaxoSmithKline's Application for Rotarix is Accepted for Review bythe FDA

August 15, 2007

• GlaxoSmithKline Updates Prescribing Information for Avandia

August 16, 2007

• Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment

August 17, 2007

• Indevus Receives Approvable Letter From FDA for Valstar for Bladder Cancer Therapy
• UCB Announces Submission of Lacosamide Marketing Application for Diabetic Neuropathic Pain
• Endo and Vernalis Provide Update on Frova

August 20, 2007

• Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
• Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
• Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for Creon

August 21, 2007

• Daiichi Sankyo and Forest Laboratories Sign Letter of Intent forCo-Promotion of Azor

August 22, 2007

• Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules
• FDA Advisory Panel to Review Medtronic's Endeavor Drug Eluting Stent in October

August 24, 2007

• Genentech Announces Resubmission of Supplemental Biologics License Application for Avastin in Combination with Paclitaxel for First-Line Metastatic Breast Cancer

August 27, 2007

• IDM Pharma Receives Not Approvable Letter for Mifamurtide(L-MTP-PE) for the Treatment of Osteosarcoma

August 28, 2007

• Indevus Announces Submission of New Drug Application for Nebido
• FDA Accepts for Review Complete Response to Approvable Letter forEntereg (alvimopan) for POI
• Schering-Plough/Merck Pharmaceuticals Announce FDA FilingAcceptance of New Drug Application for Loratadine/MontelukastTablet
• Neurochem Provides Information on Cash Position

August 29, 2007

• Merck Announces FDA Acceptance of NDA for Cordaptive (ER niacin/laropiprant), Formerly Known as MK-0524A, an Investigational Lipid-Modifier

August 30, 2007

• Cardiome And Astellas Announce Regulatory Extension

September 4, 2007

• Merck Applies to Extend Use of Erbitux for 1st-Line Colorectal Cancer
• Sciele Pharma Announces Acceptance by FDA of sNDA for New Sular Formulation

September 6, 2007

• Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium)
• FDA Advisory Committee Unanimously Recommends Accelerated Approval of Isentress (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV

September 10, 2007

• FDA Informs Endo and Vernalis That New Target Action Date on FrovasNDA Is Sept. 30, 2007

September 13, 2007

• FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals

September 14, 2007

• FDA Accepts NDA Filing for Cleviprex (Clevidipine Butyrate Injectable Emulsion) for the Treatment of Acute Hypertension

September 17, 2007

• FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)

September 20, 2007

• FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125

September 21, 2007

• Cephalon Submits New Drug Application for Treanda for the Treatmentof Chronic Lymphocytic Leukemia

September 24, 2007

• FDA Accepts sNDA for Expanded Use of Angiomax (bivalirudin)
• Nitec's IND Application for Clinical Development With LodotraAccepted by the FDA
• NexMed Files NDA for Proprietary Erectile Dysfunction Treatment

September 25, 2007

• Labopharm Provides Update on U.S. Regulatory Process for Once-DailyTramadol
• Alcon Receives FDA Decision on Retaane Suspension for Wet AMD

September 26, 2007

• Solvay Pharmaceuticals, Inc. Announces FDA Extension of Tedisamil PDUFA Date

September 27, 2007

• MGI Pharma Announces Submission of Aquavan NDA
• Prexige Receives "Not Approvable" Letter in the US Despite Being One of the Most Studied COX-2 Inhibitors
• Vanda Pharmaceuticals Submits Iloperidone New Drug Application

September 28, 2007

• CV Therapeutics Submits Supplemental New Drug Application forRanexa (ranolazine extended-release tablets)

October 1, 2007

• Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter
• Endo Pharmaceuticals and Vernalis Receive Action Letter From FDA on Frova Supplemental New Drug Application
• Lev's Cinryze BLA Accepted for Filing by FDA

October 2, 2007

• Antares Reports Product Progress in Growing Women's Health Portfolio

October 4, 2007

• Roche and Trimeris Provide Update on Development of AlternativeAdministration Options for Delivery of Fuzeon
• FzioMed's PMA Application for Oxiplex Gel Accepted for Filing by FDA

October 5, 2007

• Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days

October 8, 2007

• Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE

October 10, 2007

• Angiotech Announces Intent to File 510(k) for its Innovative 5-FUCentral Venous Catheter (CVC) Based on Positive Results fromPivotal Trial

October 11, 2007

• FDA's Psychiatric Division Has Rejected Cortex's Request to Study CX717 in Phase IIb ADHD Study
• Alcon Amends NDA for Patanase Nasal Spray
• FDA Advisory Committee Recommends Medtronic's Endeavor Drug-Eluting Stent for Approval
• Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome

October 12, 2007

• Gilead Submits Marketing Applications in the United States and European Union for Viread (Tenofovir Disoproxil Fumarate) for the Treatment of Chronic Hepatitis B
• Impending FDA Approval Decision on the First HIV Integrase Inhibitor Isentress Can Have Significant Impact for Patients

October 15, 2007

• Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for Tysabri for Crohn's Disease
• Pozen Submits Response to Approvable Letter for Trexima
• Labopharm Appeals FDA's Decision on Once-Daily Tramadol

October 17, 2007

• FDA Advisory Committee Votes in Favor of Earlier Use of PhosphateBinders in Stage 4 Kidney Disease Patients With Hyperphosphatemia

October 19, 2007

• DOR BioPharma Receives Not Approvable Letter From FDA for orBec for Treatment of Gastrointestinal Graft-vs.-Host Disease

October 22, 2007

• Abbott and Solvay Pharmaceuticals to co-promote Abbott's Simcor in the United States

October 24, 2007

• FDA Issues Approvable Letter for Stavzor Delayed Release Valproic Acid Capsules
• Biovail Submits Complete Response to FDA for BVF-033
• FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia

October 25, 2007

• Genta Completes Appeal of FDA Decision for Genasense in CLL

October 29, 2007

• Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex With Codeine
• Elan Announces the Johnson & Johnson Pharmaceutical Research & Development Submission of a New Drug Application to the FDA for Paliperidone Palmitate Using Elan's Proprietary NanoCrystal Technology

October 30, 2007

• Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data
• MGI Pharma and Helsinn Announce Submission of Supplemental New Drug Application for Aloxi Capsules

October 31, 2007

• BioDelivery Sciences Submits NDA For BEMA Fentanyl
• Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review

November 1, 2007

• FDA Accepts New Drug Application for Nebido Submitted by Indevus
• King Pharmaceuticals Files Citizen Petition with FDA Asserting ZymoGenetics Has Not Submitted Adequate Data for Approval of Its Recombinant Thrombin Product
• Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants
• Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA

November 2, 2007

• PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA

November 5, 2007

• Fabre Kramer Pharmaceuticals Receives Decision From FDA on GepironeER for Major Depressive Disorder
• Abbott Confirms FDA Advisory Panel to Review XIENCE V Drug Eluting Stent on November 29

November 6, 2007

• Camargo Pharmaceutical Services Announces Education Series on FDA 505(b)(2) Approval Route

November 12, 2007

• Cephalon Submits Supplemental New Drug Application for Fentora

November 13, 2007

• Genzyme Receives FDA Response Letter on Synvisc-One

November 14, 2007

• Rimonabant - Regulatory Update in Europe

November 15, 2007

• Abilify (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration

November 16, 2007

• Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA
• Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis

November 19, 2007

• Amarin Announces Completion of Comprehensive Data Analysis From Phase III Huntington's Disease Program

November 20, 2007

• Biovail Confirms FDA Class 2 Status For BVF-033 Submission
• FDA Accepts Ranexa sNDA and NDA for Filing
• NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product

November 21, 2007

• Roche Submits Application for FDA Approval of Actemra for theTreatment of Rheumatoid Arthritis

November 26, 2007

• Schering-Plough Announces Asenapine NDA Accepted for Filing by theU.S. FDA
• PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation

November 27, 2007

• Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application

November 28, 2007

• UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain
• Adolor and GlaxoSmithKline Announce FDA Advisory Committee toReview Entereg (alvimopan) for the Management of PostoperativeIleus (POI)

November 29, 2007

• UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy

December 3, 2007

• Immunicon Corporation Announced the Filing for FDA Clearance of the CellSearch Circulating Tumor Cell Kit for Monitoring Patients with Metastatic Androgen-Independent Prostate Cancer
• FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension
• Treanda New Drug Application for the Treatment of ChronicLymphocytic Leukemia Granted Priority Review Status by FDA

December 4, 2007

• Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis

December 6, 2007

• Genentech Provides Update from Avastin FDA Advisory Meeting
• Onset Therapeutics Announces FDA Submission for Novel Product for Topical Treatment of Genital Warts
• Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport
• Ipsen and Medicis Announce Submission of Reloxin in Aesthetics to the FDA

December 7, 2007

• FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa
• Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
• FDA Advisory Committee Votes Unanimously to Recommend Approval ofTetrabenazine for Chorea Associated With Huntington Disease
• Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of Complete Response and is Granted Class 2 Review
• DOR BioPharma Announces Results of orBec End of Review Conference with the FDA

December 10, 2007

• U.S. FDA Issues Approvable Letter for Requip XL Extended Release Tablets

December 12, 2007

• FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation
• ProEthic Pharmaceuticals Announces Acceptance of PRO-513 New Drug Application for Migraine

December 13, 2007

• Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA
• Neupro Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
• Neupro Filed with the FDA for the Treatment of Restless Legs Syndrome
• Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation

December 17, 2007

• MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA
• Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)
• GlaxoSmithKline Receives FDA 'Complete Response' Letterfor Cervarix Cervical Cancer Vaccine

December 19, 2007

• Pro-Pharmaceuticals Selects SAFC, a Division of Sigma-Aldrich, toSubmit a Drug Master File
• AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients

December 20, 2007

• Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for Advexin in Advanced Head and Neck Cancer in First Half of 2008
• GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
• Eurand Completes New Drug Application for Zentase
• Indevus Receives Non-Approvable Letter From FDA for Valstar
• Intercell Finalizes Submission of US Biological License Application (BLA) to FDA For Licensure of Japanese Encephalitis Vaccine

December 21, 2007

• ISTA Pharmaceuticals Submits New Drug Application for Xibrom QD (once-daily)
• Jerini Receives NDA Filing Acceptance and Priority Review from theFDA for Icatibant in the Treatment of HAE
• New Drug Application for Tolvaptan, Otsuka's Investigational NovelOral Treatment for Worsening Heart Failure and Hyponatremia,Accepted by the U.S. Food and Drug Administration
• Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for Promacta (eltrombopag)
• Millennium Submits sNDA for Velcade (Bortezomib) for Injection forthe Treatment of Front-Line Multiple Myeloma
• Pfizer Receives Approvable Letter from FDA for Dalbavancin
• Supplemental New Drug Application for Prezista Submitted to U.S. Food and Drug Administration

December 26, 2007

• Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis - Dec 26, 2007
• FDA Issues Approvable Letter for Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
• Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases

December 27, 2007

• Noven Announces FDA Tentative Approval of Stavzor Valproic Acid Delayed Release Capsules