New Drug Applications Archive for 2010

January 5, 2010

• Pfizer Provides U.S. Regulatory Update On Prevnar 13 Vaccine
• Biodel Submits VIAject New Drug Application to FDA for Treatment of Diabetes

January 6, 2010

• Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia
• ADVENTRX Pharmaceuticals Submits ANX-530 New Drug Application
• FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF

January 11, 2010

• MAP Pharmaceuticals Announces FDA Will Not Require a Second Pivotal Efficacy Study for Levadex NDA Submission

January 13, 2010

• MannKind Updates Status of Afrezza New Drug Application

January 21, 2010

• Genzyme's Lumizyme BLA Receives Six-Month FDA Review

January 25, 2010

• Somaxon Provides Update on New Drug Application for Silenor for the Treatment of Insomnia

January 28, 2010

• FDA Issues Complete Response Letter for Low Dose Oral Contraceptive WC 3016

January 29, 2010

• FDA Extends PDUFA Action Date for Stedesa New Drug Application

February 2, 2010

• Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease
• Teva Announces FDA Accepts BLA for XM02
• FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review

February 4, 2010

• XenoPort Announces Horizant as Brand Name for XP13512
• Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis

February 8, 2010

• Repros Submits Response to FDA Regarding Androxal Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility

February 9, 2010

• Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program
• FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions
• Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010

February 10, 2010

• Biovail Enters into License and Collaboration Agreement with Alexza for AZ-004
• XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010

February 11, 2010

• Cadence Pharmaceuticals Receives Complete Response Letter from FDA for Intravenous Acetaminophen NDA

February 17, 2010

• CombinatoRx Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010
• Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA

February 18, 2010

• GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS
• Alexza Announces AZ-004 (Staccato Loxapine) PDUFA Goal Date of October 11, 2010

February 19, 2010

• Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
• Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter

February 23, 2010

• Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review

February 24, 2010

• Arena Pharmaceuticals Announces FDA Acceptance of Lorcaserin NDA for Filing

February 25, 2010

• Theratechnologies Announces a Tentative New Date for the FDA Advisory Committee Review of the tesamorelin New Drug Application

February 26, 2010

• Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA

March 1, 2010

• FDA Accepts VIAject NDA for Review
• Vion Pharmaceuticals Receives Response From FDA on Special Protocol Assessment for Onrigin

March 2, 2010

• FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients
• U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro
• Adventrx Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
• VIVUS Announces FDA Acceptance of Qnexa New Drug Application for Treatment of Obesity
• FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone

March 5, 2010

• InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone

March 8, 2010

• NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12

March 9, 2010

• Actelion Pharmaceuticals Ltd (CH) - Actelion receives FDA complete response letter for Zavesca (miglustat) for the treatment of Niemann-Pick type C disease
• ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay

March 10, 2010

• FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis
• Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia

March 15, 2010

• FDA Requests Additional Information Regarding Afrezza in Complete Response Letter to MannKind

March 19, 2010

• A.P. Pharma Receives FDA Complete Response Letter for APF530
• Adventrx Receives Brand Name Acceptance for ANX-530
• Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy

March 22, 2010

• U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults
• FDA Confirms Date for Advisory Committee Review of the Tesamorelin New Drug Application
• CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

March 23, 2010

• Clinical Data Submits NDA for Depression Compound

March 24, 2010

• U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of Omapro in Chronic Myeloid Leukemia Patients with T315I Mutation

March 25, 2010

• Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA

March 26, 2010

• VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity

March 30, 2010

• AstraZeneca and Abbott Receive FDA Complete Response Letter on Certriad New Drug Application
• New drug application for voclosporin accepted for priority review by FDA
• Ikaria Acquires New Drug Application for Lucassin
• Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA
• Lux Biosciences' Luveniq Receives FDA Priority Review

March 31, 2010

• Depomed Announces Submission of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796
• Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU
• Orexigen Therapeutics Submits Contrave New Drug Application to FDA for the Treatment of Obesity

April 9, 2010

• CTI Receives Complete Response Letter from the FDA for Pixantrone NDA; CTI to File for Expanded Access for Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

April 12, 2010

• ChemGenex Receives a Complete Response Letter from the FDA for Omapro

April 19, 2010

• Cadence Pharmaceuticals Announces Plan to Resubmit NDA for Ofirmev

April 23, 2010

• Acura Pharmaceuticals and King Pharmaceuticals Provide Update on FDA Advisory Committee Meeting For Acurox
• Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for Bydureon

April 27, 2010

• Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S., an Investigational Compound for the Treatment of Hypertension

April 30, 2010

• AVANIR Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zenvia in PBA

May 3, 2010

• Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept
• Adventrx to Resubmit ANX-530 NDA in the Fourth Quarter of 2010

May 4, 2010

• King Pharmaceuticals and Acura Pharmaceuticals Announce Plans to Submit an NDA for Acurox Tablets without Niacin
• FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa

May 5, 2010

• Cadence Pharmaceuticals Resubmits New Drug Application for Ofirmev
• InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application

May 6, 2010

• Bydureon FDA Review Timeline Set with PDUFA Action Date of October 22, 2010

May 7, 2010

• Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA

May 11, 2010

• FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq

May 13, 2010

• NicOx provides update on FDA Advisory Committee Meeting for naproxcinod

May 17, 2010

• Amgen Submits Denosumab Biologics License Application to FDA for the Reduction of Skeletal Related Events in Cancer Patients
• Cadence Pharmaceuticals Announces Ofirmev NDA Action Date of November 4, 2010
• Avanir Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010
• Sigma-Tau Pharmaceuticals Cysteamine Eye Drop NDA Accepted for Filing

May 18, 2010

• Nycomed And Forest Laboratories Receive Complete FDA Response Letter For Roflumilast

May 19, 2010

• Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder
• Discovery Labs Achieves Key Milestone Towards Potential Surfaxin Approval

May 24, 2010

• Clinical Data, Inc. Announces FDA Acceptance of New Drug Application for Vilazodone for the Treatment of Major Depressive Disorder

May 25, 2010

• Novartis Announces Extension of US Regulatory Priority Review Period for FTY720, an Investigational Once-daily Oral Multiple Sclerosis Therapy

May 26, 2010

• Horizon Pharma, Inc. Announces FDA Acceptance of Duexa New Drug Application for Filing

June 1, 2010

• AstraZeneca Receives FDA Complete Response Letter for Axanum New Drug Application

June 3, 2010

• FDA Advisory Committee Reviews MedImmune's Motavizumab

June 7, 2010

• OPAXIO Phase II Study Results Confirm High Rate of Complete Response with Low Rate of Side Effects in Patients with Advanced Esophageal Cancer
• Theratechnologies announces positive vote by FDA Advisory Committee for tesamorelin

June 8, 2010

• Depomed Announces Acceptance of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796
• Merck Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy
• Discovery Labs Receives FDA Guidance Regarding Preclinical Program to Gain Surfaxin Approval

June 10, 2010

• Human Genome Sciences Announces Submission of Biologics License Application to FDA for Benlysta (belimumab)

June 11, 2010

• H. Lundbeck A/S (DK) - Lundbeck will submit an NDA for clobazam for patients with Lennox-Gastaut syndrome with the FDA before year end 2010
• FDA Advisory Committee Unanimously Recommends Approval Of Novartis Investigational Treatment FTY720 To Treat Relapsing Remitting MS

June 14, 2010

• Human Genome Sciences Announces Preliminary Feedback From FDA on Zalbin BLA for Chronic Hepatitis C

June 15, 2010

• Orexo confirms Abstral PDUFA date update
• Orexigen Therapeutics Announces FDA Acceptance of Contrave New Drug Application for the Treatment of Obesity

June 18, 2010

• FDA Advisory Committee Unanimously Recommends Approval of HRA Pharma's Ulipristal Acetate for Emergency Contraception

June 21, 2010

• BioSante Pharmaceuticals Says FDA Advisory Committee Recommendation Against Flibanserin has No Impact on LibiGel

June 22, 2010

• Biovest Announces Mantle Cell Lymphoma as Next Target Indication for Personalized Cancer Vaccine

June 23, 2010

• FDA cancels advisory committee meeting for voclosporin - Priority review of Lux Biosciences ' NDA continues

June 24, 2010

• Orexigen Therapeutics Announces Date of FDA Advisory Committee Review of Contrave for the Treatment of Obesity

June 25, 2010

• Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010

June 29, 2010

• EpiCept Files New Drug Application for Ceplene in AML
• pSivida Announces Submission of NDA to FDA for an Ophthalmic Product for Diabetic Macular Edema

July 1, 2010

• Endo Pharmaceuticals Completes Next Step in Regulatory Process for Fortesta for Men With Low Testosterone

July 7, 2010

• Winston Laboratories, Inc. Submits NDA for Civanex (Civamide Cream) for Treatment of Osteoarthritis

July 12, 2010

• Protalix BioTherapeutics Receives PDUFA Date for taliglucerase alfa

July 13, 2010

• Human Genome Sciences and Lonza Enter Commercial Manufacturing Agreement for Benlysta, a Potential New Treatment for Systemic Lupus Erythematosus

July 16, 2010

• Vivus Comments on FDA Advisory Committee Panel Meeting on Qnexa (phentermine/topiramate) Controlled Release Capsules for the Treatment of Obesity
• ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro

July 20, 2010

• FDA Accepts Afrezza Complete Response Resubmission and Sets Target Action Date

July 22, 2010

• Theratechnologies: Update on timeline for FDA Action Date
• FDA provides Complete Response Letter to NicOx's New Drug Application for naproxcinod

July 26, 2010

• Tibotec Pharmaceuticals Submits New Drug Application for Investigational Once-Daily HIV Treatment TMC278 to U.S. Food and Drug Administration

July 28, 2010

• FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis

July 29, 2010

• FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes

August 6, 2010

• FDA Confirms September 16th Advisory Committee Meeting to Review Lorcaserin for Obesity and Weight Management

August 10, 2010

• Lux Biosciences Receives Complete Response Letter from FDA for Luveniq

August 12, 2010

• Ezogabine, an Investigational Anti-Epileptic Drug, Receives Positive Vote from FDA Advisory Committee

August 18, 2010

• Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma

August 19, 2010

• Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for Benlysta (belimumab) as a Potential Treatment for Systemic Lupus Erythematosus

August 23, 2010

• EpiCept Corporation Receives Refusal to File Letter from US FDA on Ceplene New Drug Application
• Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia

August 30, 2010

• Eisai Announces Extension of FDA Review of Drug Application for Investigational Agent Eribulin Mesylate

August 31, 2010

• pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macular Edema

September 7, 2010

• Update on the FDA review for Abstral
• Medimmune Receives Complete Response Letter On Motavizumab

September 8, 2010

• FDA Advisory Committee Recommends Approval of Forest Laboratories' Ceftaroline Fosamil for the Treatment of Community Acquired Bacterial Pneumonia and Complicated Skin and Skin Structure Infections

September 13, 2010

• Forest Responds to FDA Complete Response Letter for Roflumilast

September 14, 2010

• Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma

September 15, 2010

• Obesity Expert to Speak to FDA in Support of Treatment Options for Obese Patients
• US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application

September 17, 2010

• Arena and Eisai Provide Update on Lorcaserin FDA Advisory Committee Meeting

September 21, 2010

• Optimer Pharmaceuticals Submits Rolling New Drug Application to FDA for Fidaxomicin
• FDA Advisory Committee Unanimously Recommends Approval of Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation

September 23, 2010

• US and EU Regulatory Submissions for Vandetanib in Advanced Medullary Thyroid Cancer Accepted for Review

October 5, 2010

• Human Genome Sciences Receives Complete Response Letter from FDA on Zalbin BLA for Chronic Hepatitis C
• ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro

October 8, 2010

• Onyx Pharmaceuticals Provides Status Update on Carfilzomib
• Following Regulatory Feedback Boehringer Ingelheim Decides to Discontinue Flibanserin Development

October 11, 2010

• Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato Loxapine) NDA
• Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia

October 20, 2010

• Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for Bydureon

October 25, 2010

• FDA Issues Complete Response Letter for Lorcaserin New Drug Application

October 29, 2010

• FDA Issues Complete Response Letter to Vivus Regarding New Drug Application for Qnexa

November 1, 2010

• FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta

November 2, 2010

• Bristol-Myers Squibb Announces that the U.S. Food and Drug Administration Has Extended the Review Timeline for the Ipilimumab Biologics License Application

November 5, 2010

• Adventrx Submits Exelbine New Drug Application

November 8, 2010

• GlaxoSmithKline and XenoPort Respond to FDA on Horizant for RLS

November 9, 2010

• EUSA Pharma Submits Erwinase Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia

November 16, 2010

• Clinical Data, Inc. Announces Issuance of New U.S. Patent for Vilazodone

November 17, 2010

• Human Genome Sciences and GlaxoSmithKline Announce Vote of FDA Advisory Committee to Recommend Approval of Benlysta for Systemic Lupus Erythematosus

November 22, 2010

• Paclitaxel Poliglumex (OPAXIO) Combined with Temozolomide and Radiotherapy Demonstrates High Response Rates with Encouraging Progression Free Survival in Malignant Brain Cancer

November 23, 2010

• Vertex Completes New Drug Application for Telaprevir for Hepatitis C

November 29, 2010

• Affymax and Takeda Confirm U.S. Registration Strategy for Investigational Drug, Hematide/peginesatide, Following Meeting with FDA
• Merck KGaA Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of MS

November 30, 2010

• Optimer Pharmaceuticals Completes New Drug Application for Fidaxomicin and Requests Priority Review From FDA

December 2, 2010

• GSK and Valeant Announce Receipt of U.S. FDA Complete Response Letter for ezogabine

December 3, 2010

• US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
• Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma

December 6, 2010

• GlaxoSmithKline and Human Genome Sciences announce FDA extension of Benlysta PDUFA target date to 10th March 2011

December 7, 2010

• Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato Loxapine)

December 8, 2010

• Orexigen Therapeutics' Investigational Drug Contrave Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity

December 14, 2010

• Pacira Pharmaceuticals Announces FDA Acceptance of Exparel New Drug Application for Pain Management
• VIVUS Submits Briefing Document to FDA, Announces Follow-up Meeting to Discuss QNEXA

December 17, 2010

• AstraZeneca Receives Complete Response Letter From US FDA For Brilinta (ticagrelor Tablets)

December 20, 2010

• Chelsea Therapeutics Accelerates Northera NDA Filing Following Meeting With FDA
• Fibrocell Science, Inc. Submits Complete Response to FDA Regarding Azficel-T
• King Pharmaceuticals and Acura Pharmaceuticals Announce Submission of New Drug Application for Acurox Tablets
• Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Application for Metreleptin to Treat Rare Forms of Lipodystrophy

December 21, 2010

• Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastatic Advanced Prostate Cancer

December 22, 2010

• Antares Pharma Announces Filing of New Drug Application for Anturol for Overactive Bladder
• Arena and Eisai Complete End-of-Review Meeting with FDA for Lorcaserin New Drug Application
• Abbott and AstraZeneca End License Agreement for the Development of Certriad

December 26, 2010

• FDA Issues Complete Response Letter Regarding New Drug Application for Iluvien

December 27, 2010

• King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy

December 28, 2010

• MannKind Updates Status of New Drug Application for Afrezza
• Pharming And Santarus Announce Submission Of Rhucin Biologics License Application to FDA