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
January 13, 2010
January 21, 2010
January 25, 2010
January 28, 2010
January 29, 2010
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
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
February 24, 2010
February 25, 2010
February 26, 2010
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
March 8, 2010
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
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
March 24, 2010
March 25, 2010
March 26, 2010
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
April 12, 2010
April 19, 2010
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
April 30, 2010
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
May 7, 2010
May 11, 2010
May 13, 2010
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
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
May 25, 2010
May 26, 2010
June 1, 2010
June 3, 2010
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
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
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
June 21, 2010
June 22, 2010
June 23, 2010
June 24, 2010
June 25, 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
July 7, 2010
July 12, 2010
July 13, 2010
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
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
July 28, 2010
July 29, 2010
August 6, 2010
August 10, 2010
August 12, 2010
August 18, 2010
August 19, 2010
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
August 31, 2010
September 7, 2010
September 8, 2010
September 13, 2010
September 14, 2010
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
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
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
October 25, 2010
October 29, 2010
November 1, 2010
November 2, 2010
November 5, 2010
November 8, 2010
November 9, 2010
November 16, 2010
November 17, 2010
November 22, 2010
November 23, 2010
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
December 2, 2010
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
December 7, 2010
December 8, 2010
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
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
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
December 27, 2010
December 28, 2010
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