FDA Drug Approvals
See also: Generic Approvals, New Drug Applications, Recent Additions to Drugs.com, Approval Process, New Indications and Dosage forms
Latest New Drug Approvals
Date of Approval: August 15, 2008
Company: Prestwick Pharmaceuticals, Inc.
Treatment for: Huntington’s Chorea
Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.
- Xenazine (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease - August 15, 2008
- FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease - December 7, 2007
- Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease - March 31, 2006
Date of Approval: August 1, 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: 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: 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: 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 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: 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: 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: May 20, 2008
Company: Adolor Corporation
Treatment for: Postoperative Ileus
Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.
- Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI) - May 21, 2008
- Adolor Provides Regulatory Update on Entereg (alvimopan) - May 9, 2008
- FDA Extends Review of NDA for Entereg (alvimopan) - February 11, 2008
- Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for Entereg (alvimopan) for the Management of Postoperative Ileus in Bowel Resection - January 24, 2008
- Adolor Announces Availability of Briefing Documents For January 23rd FDA Advisory Committee Meeting on Entereg (alvimopan) - January 18, 2008
- Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg (alvimopan) for the Management of Postoperative Ileus (POI) - November 28, 2007
- FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI - August 28, 2007
- GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program - June 11, 2007
- FDA Issues Approvable Letter for Entereg (alvimopan) for POI - November 6, 2006
- Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA - May 31, 2006
- Adolor Receives FDA Approvable Letter for Entereg - July 22, 2005
- Adolor Announces FDA Update - January 10, 2005
- FDA Accepts Entereg for Review - September 8, 2004
- Adolor Completes Submission of NDA for Entereg - June 28, 2004
- Adolor Submits Second Portion of NDA for Entereg - June 1, 2004
- Adolor Submits First Portion of NDA for Entereg - May 7, 2004
Date of Approval: May 9, 2008
Company: Novalar Pharmaceuticals, Inc.
Treatment for: Reversal of Anesthesia
OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures.
Date of Approval: April 25, 2008
Company: Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals
Treatment for: Opioid-Induced Constipation
Relistor is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.
- Progenics and Wyeth Announce FDA Has Approved Relistor - April 25, 2008
- Progenics and Wyeth Announce NDA Review Period for Subcutaneous Methylnaltrexone Extended by Three Months - January 10, 2008
- Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone - May 31, 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 - March 30, 2007
Date of Approval: April 23, 2008
Company: Biovail Corporation
Treatment for: Depression
Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.
- Biovail Receives FDA Approval for Aplenzin (BVF-033) - April 24, 2008
Date of Approval: April 22, 2008
Company: UCB, Inc.
Treatment for: Crohn's Disease -- Acute
Cimzia is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease in adults.
- Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease - April 22, 2008
- FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid Arthritis - February 6, 2008
- UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US - March 23, 2007
- UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease - March 2, 2006
Date of Approval: April 15, 2008
Company: Pozen Inc.
Treatment for: Migraine
Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.
- Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine - April 16, 2008
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) - January 16, 2008
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - November 1, 2007
- Pozen Submits Response to Approvable Letter for Trexima - October 15, 2007
- Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days - October 5, 2007
- FDA Issues Second Approvable Letter for Trexima - August 2, 2007
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - March 22, 2007
- Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End - December 13, 2006
- Pozen Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006
- Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter - July 31, 2006
- Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment - June 9, 2006
- GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA - October 11, 2005
- POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine - August 8, 2005
Date of Approval: April 15, 2008
Company: Alcon, Inc.
Treatment for: Allergic Rhinitis
Patanase (olopatadine) is an antihistamine nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.
- Alcon's Patanase Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms - April 16, 2008
- Alcon Amends NDA for Patanase Nasal Spray - October 11, 2007
FDA Drug Approvals Archive
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