FDA Drug Approvals
See also: Generic Approvals, New Drug Applications, Recent Additions to Drugs.com, Approval Process
Latest New Drug Approvals
Date of Approval: August 4, 2008
Company: The Medicines Company
Treatment for: Hypertension
Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.
- The Medicines Company’s Cleviprex Receives FDA Approval - August 4, 2008
- FDA Accepts NDA Filing for Cleviprex (Clevidipine Butyrate Injectable Emulsion) for the Treatment of Acute Hypertension - September 14, 2007
Date of Approval: June 20, 2007
Company: Novartis
Treatment for: Hypertension
Exforge is a single-tablet combination of an angiotensin receptor blocker (valsartan) and a calcium channel blocker (amlodipine) taken once-daily for the treatment of hypertension.
- Single-Pill Combinations Diovan HCT and Exforge Approved in US as First-Line Treatments for High Blood Pressure - August 4, 2008
- Exforge Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure - June 21, 2007
- US Submission of Exforge Accepted for Review by the FDA - April 27, 2006
Date of Approval: December 21, 1988
Company: EKR Therapeutics, Inc.
Treatment for: Hypertension, Angina Pectoris
Cardene (nicardipine) is a calcium channel blocker for the treatment of hypertension and angina.
- FDA Approves New Cardene Formulation - August 1, 2008
Date of Approval: July 29, 2008
Company: Noven Pharmaceuticals, Inc.
Treatment for: Bipolar Disorder, Seizures, Epilepsy, Migraine Prophylaxis
Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
- Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches - July 30, 2008
- Noven Announces FDA Tentative Approval of Stavzor Valproic Acid Delayed Release Capsules - December 27, 2007
- FDA Issues Approvable Letter for Stavzor Delayed Release Valproic Acid Capsules - October 24, 2007
Date of Approval: July 24, 2008
Company: Alcon Laboratories, Inc.
Treatment for: Intraocular Irrigation
Navstel is a balanced salt ophthalmic solution for use as an intraocular irrigation during surgical procedures involving perfusion of the eye.
- FDA Approves Navstel Intraocular Irrigating Solution - July 24, 2008
Date of Approval: July 3, 2008
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnostic
Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.
Date of Approval: August 19, 1999
Company: Eisai Corporation of North America
Treatment for: Gastroesophageal Reflux Disease, Duodenal Ulcer, Helicobacter pylori Infection, Zollinger-Ellison Syndrome
Aciphex (rabeprazole) is a proton-pump inhibitor indicated for the treatment of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid.
- FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents - July 1, 2008
Date of Approval: June 27, 2008
Company: OrthoNeutrogena
Treatment for: Facial Wrinkles
Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.
Date of Approval: July 27, 2004
Company: PhotoCure ASA
Treatment for: Keratosis
Metvixia is a non-invasive treatment which combines the local application of cream and illumination with a proprietary red light source (CureLight/Aktilite) to activate the drug for the photodynamic treatment of sun-induced pre-cancerous skin lesions (actinic keratosis).
- Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy - June 27, 2008
- FDA Approves Metvixia for Actinic Keratosis - July 27, 2004
- U.S. New Drug Application Approval Expected for Metvix - June 17, 2004
Date of Approval: August 1, 2000
Company: Johnson & Johnson Pharmaceutical Research & Development LLC
Treatment for: Attention Deficit Disorder
Concerta (methylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.
- FDA Approves Concerta (methylphenidate HCl) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults - June 27, 2008
Date of Approval: June 24, 2008
Company: GlaxoSmithKline
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis Prophylaxis, Pertussis Prophylaxis
Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children.
- FDA Approves Kinrix - New Combination Vaccine for Children - June 25, 2008
Date of Approval: June 22, 2005
Company: Boehringer Ingelheim
Treatment for: HIV Infection
Aptivus is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection.
- New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients - June 24, 2008
- Aptivus (tipranavir) Capsules Granted Full Approval by the U.S. FDA - October 5, 2007
- Aptivus Boehringer Ingelheim - Treatment for HIV Infection - June 22, 2005
- FDA Antiviral Drugs Advisory Committee Recommends Accelerated Approval for Investigational Anti-HIV Drug Tipranavir - May 19, 2005
- Boehringer Ingelheim Submits New Drug Application to U.S. Food and Drug Administration for Tipranavir - October 25, 2004
Date of Approval: June 23, 2008
Company: Sirion Therapeutics, Inc.
Treatment for: Postoperative Ocular Inflammation
Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.
- Sirion Therapeutics Announces FDA Approval of Durezol for Treatment of Postoperative Ocular Inflammation and Pain - June 24, 2008
- Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol in the Treatment of Postoperative Ocular Inflammation - February 27, 2008
Date of Approval: June 23, 2008
Company: Sciele Pharma, Inc. and Novo Nordisk Inc.
Treatment for: Diabetes Mellitus Type II
PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes.
- FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes - June 24, 2008
Date of Approval: May 13, 2003
Company: Millennium Pharmaceuticals
Treatment for: Multiple Myeloma
Velcade is an antineoplastic agent indicated for the treatment of multiple myeloma.
- FDA Approves Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma - June 23, 2008
- FDA Expands Velcade (Bortezomib) for Injection Label for Patients with Multiple Myeloma - October 15, 2007
- Velcade Millennium Pharmaceuticals - Treatment for Multiple Myeloma - May 13, 2003
Date of Approval: June 20, 2008
Company: Sanofi pasteur
Treatment for: Pertussis Prophylaxis, Tetanus Prophylaxis, Diphtheria Prophylaxis, Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis
Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.
- U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel - June 23, 2008
- FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine - January 25, 2007
- FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, Pentacel - September 26, 2005
Date of Approval: November 20, 2001
Company: GlaxoSmithKline
Treatment for: Benign Prostatic Hyperplasia
Avodart (dutasteride) is a 5á-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH).
- FDA Approves GlaxoSmithKline's Avodart in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate - June 20, 2008
Date of Approval: June 16, 2008
Company: Allergan, Inc.
Treatment for: Ocular Inflammatory Conditions
Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
- Allergan Receives U.S. Food and Drug Administration Approval for Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL - June 17, 2008
Date of Approval: August 3, 2004
Company: Eli Lilly and Company
Treatment for: Depression, Anxiety, Fibromyalgia, Diabetic Neuropathy
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta is indicated for the treatment of major depressive disorder, neuropathic pain associated with diabetic peripheral neuropathy, generalized anxiety disorder and fibromyalgia.
- FDA Approves Cymbalta for the Management of Fibromyalgia - June 16, 2008
- FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder - November 30, 2007
- FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder - February 26, 2007
- FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes - September 7, 2004
- FDA Approves Cymbalta for the Treatment of Depression - August 4, 2004
- FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data - June 24, 2004
Date of Approval: September 19, 1997
Company: GlaxoSmithKline
Treatment for: Parkinson's Disease
Requip (ropinirole) is a non-ergoline dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
- U.S. FDA Approves Requip XL, the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease - June 16, 2008
- FDA Approves Requip for Parkinson’s Disease - September 19, 1997
FDA Drug Approvals Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Oct | Dec
