New Drug Applications Archive for 2012
January 3, 2012
January 4, 2012
January 5, 2012
January 9, 2012
January 10, 2012
January 19, 2012
January 23, 2012
January 30, 2012
- Cell Therapeutics Withdraws New Drug Application for Pixuvri and Plans to Resubmit in 2012
- Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph+ Chronic Myeloid Leukemia
January 31, 2012
February 1, 2012
February 7, 2012
- Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy
- FDA Grants Genentech's Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer
February 8, 2012
February 14, 2012
February 15, 2012
- Santarus Announces FDA Acceptance of Uceris New Drug Application for Induction of Remission of Active Ulcerative Colitis
- FDA Accepts Pfizer's New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
February 23, 2012
- FDA Advisory Committee Recommends Approval of Qnexa
- FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson's Disease
February 24, 2012
- Forest and Almirall Announce Positive FDA Advisory Committee's Recommendation for Approval of Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
- FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH
February 28, 2012
March 1, 2012
March 5, 2012
March 8, 2012
March 21, 2012
March 26, 2012
March 28, 2012
March 29, 2012
April 2, 2012
- Raptor Pharmaceutical Corp. Submits New Drug Application for RP103 for the Potential Treatment of Nephropathic Cystinosis
- Tekmira Provides Update on Licensed Product Candidate, Marqibo
April 3, 2012
April 4, 2012
April 5, 2012
- Sanofi and Regeneron Announce Regulatory and Clinical Update for Zaltrap (aflibercept)
- FDA Advisory Committee Recommends Approval of Mirabegron - Investigational Overactive Bladder Treatment from Astellas
April 10, 2012
April 12, 2012
April 18, 2012
- Depomed Announces Intent to File NDA for Serada for Treatment of Menopausal Hot Flashes
- Inspiration Biopharmaceuticals Announces Filing of Biologics License Application (BLA) for IB1001, a Recombinant Factor IX Product for People with Hemophilia B
April 26, 2012
April 27, 2012
- The International Myeloma Foundation Says Pomalidomide, an Important New Drug for Patients, Has Been Submitted for FDA Approval
- Takeda Receives Complete Response Letter from the FDA for Type 2 Diabetes Investigational Therapies Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone
- Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
- Dynavax Reports Heplisav BLA Submission
April 30, 2012
May 2, 2012
May 3, 2012
- Alexza Receives Complete Response Letter for Adasuve NDA
- Napo Comments on FDA Announcing Extension of Crofelemer NDA Priority Review
May 7, 2012
May 9, 2012
- Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy
- FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
- US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review
May 10, 2012
May 11, 2012
May 22, 2012
- Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA
- Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration-Resistant Prostate Cancer in Patients Previously Treated with Chemotherapy
May 23, 2012
- Bayer Submits New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer
May 25, 2012
May 29, 2012
May 30, 2012
May 31, 2012
June 1, 2012
June 6, 2012
June 7, 2012
- Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
- ThromboGenics Receives Notice From FDA of Advisory Committee Meeting for Ocriplasmin
June 12, 2012
- Genzyme Submits Applications to FDA and EMA for Approval of Lemtrada (alemtuzumab) for Multiple Sclerosis
- Tokai Pharmaceuticals' Galeterone Receives Fast Track Designation from the FDA for the Treatment of Advanced Prostate Cancer
June 15, 2012
June 18, 2012
June 19, 2012
June 21, 2012
- Onyx Pharmaceuticals' Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC)
June 25, 2012
- MAP Pharmaceuticals Provides Update Following Meeting with FDA for Levadex (dihydroergotamine) New Drug Application
- Bristol-Myers Squibb and Pfizer Receive Complete Response Letter From U.S. Food and Drug Administration for Eliquis (Apixaban)
- Repligen Receives Complete Response Letter from FDA for RG1068 NDA
June 27, 2012
- Dynavax Announces FDA Acceptance of Heplisav BLA
- Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA
June 28, 2012
June 29, 2012
July 2, 2012
July 3, 2012
- Chelsea Therapeutics Provides an Update on Northera (droxidopa) Regulatory Status and Development Program
- ThromboGenics Announces FDA Accepts Filing and Grants Priority Review to Its Biologics License Application for Ocriplasmin Intravitreal Injection
July 6, 2012
July 10, 2012
July 16, 2012
July 26, 2012
July 27, 2012
- FDA Advisory Committee Recommends ThromboGenics' Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion (VMA)
- Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone
July 30, 2012
August 1, 2012
- Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome
- pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials
August 2, 2012
August 13, 2012
- NPS Pharmaceuticals Announces Extension of Action Date for Gattex NDA to December 30, 2012
- Ariad Announces Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
- Santarus Announces FDA Extension of Uceris New Drug Application Target Action Date to January 16, 2013
August 14, 2012
August 17, 2012
August 20, 2012
August 21, 2012
- U.S. Food And Drug Administration Extends Action Date For Tofacitinib New Drug Application By Three Months
- NPS Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Gattex (teduglutide)
August 24, 2012
August 27, 2012
- Genzyme Provides Update on U.S. Lemtrada Filing
- New Novartis Phase II data Show LCZ696 May Provide Clinical Benefits in Patients with a Difficult-to-Treat Form of Heart Failure
August 29, 2012
- Dynavax Announces FDA Advisory Committee to Review Heplisav
- Noven Submits New Drug Application for Investigational Non-Hormonal Therapy for Menopausal Vasomotor Symptoms
August 30, 2012
- Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
- Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST)
- Exelixis Provides Update on ODAC Panel for Cabozantinib
September 5, 2012
- FDA Continues Review of Crofelemer New Drug Application beyond PDUFA Goal Date of September 5, 2012
- U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
- NPS Pharmaceuticals Expects to File Natpara BLA in Mid-2013
September 13, 2012
September 19, 2012
September 24, 2012
September 26, 2012
- GSK and Theravance Announce FDA Acceptance of FF/VI New Drug Application (NDA) Submission in the US for COPD
- FDA Acknowledges Receipt of Resubmission of the Eliquis (apixaban) New Drug Application to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation
September 27, 2012
September 28, 2012
October 1, 2012
October 3, 2012
October 12, 2012
- FDA Posts Briefing Documents for Advisory Committee Meeting Reviewing Gattex (teduglutide) for Adult Short Bowel Syndrome
- Impax Pharmaceuticals Announces Extension of Rytary FDA Review Date to January 21, 2013
October 15, 2012
October 16, 2012
- A.P. Pharma Announces PDUFA Action Date for APF530 New Drug Application Resubmission
- MAP Pharmaceuticals Resubmits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug
- FDA Advisory Committee Unanimously Recommends Approval of Gattex (teduglutide) for Adults with Short Bowel Syndrome (SBS)
October 18, 2012
October 19, 2012
October 22, 2012
October 23, 2012
October 24, 2012
October 29, 2012
November 1, 2012
November 2, 2012
November 7, 2012
November 8, 2012
November 13, 2012
November 14, 2012
- FDA Accepts Noven's NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms
November 16, 2012
- Dynavax Announces FDA Advisory Committee Meeting Outcome for Heplisav
- Zogenix Announces FDA Advisory Committee Review of Zohydro ER for the Management of Chronic Pain
November 19, 2012
November 28, 2012
- AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
- Forest Laboratories Submits New Drug Application for Cariprazine for the Treatment of Both Schizophrenia and Manic or Mixed Episodes Associated with Bipolar I Disorder
November 29, 2012
December 10, 2012
December 12, 2012
- FDA Accepts Takeda and Lundbeck's Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder
- Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
December 14, 2012
- Actelion Announces acceptance of the New Drug Application for macitentan by the US Food and Drug Administration
- U.S. Food and Drug Administration (FDA) Accepts New Drug Application For Bazedoxifene/Conjugated Estrogens, An Investigational Treatment For Symptoms Associated With Menopause And Prevention of Osteoporosis
December 17, 2012
December 18, 2012
December 27, 2012
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