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: November 14, 2008
Company: Eisai Medical Research Inc.
Treatment for: Lennox-Gastaut Syndrome
Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.
- FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder - November 17, 2008
- Eisai Resubmits NDA for the Anti-epilepsy Drug Rufinamide - November 18, 2005
- Eisai Submits New Drug Application to the FDA for Anti-epileptic Drug Rufinamide - September 13, 2005
Date of Approval: October 31, 2008
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Ulcerative Colitis
Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.
- Apriso Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis - November 3, 2008
Date of Approval: October 31, 2008
Company: Pfizer Inc.
Treatment for: Urinary Frequency
Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
- Pfizer's Toviaz (fesoterodine fumarate) Receives FDA Approval for the Treatment of Overactive Bladder - October 31, 2008
Date of Approval: October 28, 2008
Company: UCB
Treatment for: Seizures
Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.
- UCB's Vimpat Approved By U.S. FDA As Adjunctive Therapy for Partial Onset Seizures in Adults - October 29, 2008
- UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain - July 29, 2008
- UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy - November 29, 2007
- UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain - November 28, 2007
Date of Approval: October 24, 2008
Company: Duramed Pharmaceuticals, Inc.
Treatment for: Contraception
LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.
- FDA Approves Duramed's LoSeasonique Oral Contraceptive - October 27, 2008
- Duramed's Lo Seasonique NDA Accepted for Filing by FDA - February 25, 2008
Date of Approval: October 21, 2008
Company: Dow Pharmaceutical Sciences, Inc.
Treatment for: Acne
Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.
- FDA Approves Acanya - October 21, 2008
Date of Approval: October 15, 2008
Company: Meda AB
Treatment for: Allergic Rhinitis
Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.
- FDA Approves Astepro - October 17, 2008
Date of Approval: October 10, 2008
Company: Lev Pharmaceuticals, Inc.
Treatment for: Angioedema
Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).
- Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks - October 13, 2008
- Lev Pharmaceuticals Announces Cinryze Complete Response Submission Accepted for Review by FDA - May 6, 2008
- Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze for Hereditary Angioedema - May 2, 2008
- Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema - April 15, 2008
- Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (C1 inhibitor) - March 13, 2008
- Lev Pharmaceuticals Receives Complete Response Letter for Cinryze - January 31, 2008
- Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data - October 30, 2007
- Lev's Cinryze BLA Accepted for Filing by FDA - October 1, 2007
- Lev Pharmaceuticals Submits Biologics License Application for Cinryze - July 31, 2007
Date of Approval: October 8, 2008
Company: Watson Pharmaceuticals, Inc.
Treatment for: Benign Prostatic Hyperplasia
Rapaflo (silodosin) is an alpha(1)- adrenoreceptor antagonist for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate.
- Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH) - October 9, 2008
- Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia - February 12, 2008
Date of Approval: October 7, 2008
Company: Akorn, Inc.
Treatment for: Ocular Anesthesia
Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.
- Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5% - October 8, 2008
- Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5% - June 4, 2008
- Akorn, Inc. Announces the New Drug Application Filing for Akten - June 29, 2007
Date of Approval: September 19, 2008
Company: GE Healthcare
Treatment for: Diagnostic
AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.
- FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection) Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults - September 19, 2008
Date of Approval: September 12, 2008
Company: ProStrakan Group plc
Treatment for: Nausea/Vomiting -- Chemotherapy Induced
Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.
- FDA Approves Sancuso, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy - September 15, 2008
- ProStrakan Presents Update on Sancuso US Regulatory Review Status - June 2, 2008
Date of Approval: August 22, 2008
Company: Amgen Inc.
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - August 22, 2008
- Amgen's FDA Nplate Approval Statement Retracted - July 15, 2008
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - July 14, 2008
- Amgen Statement on Successful Outcome of Romiplostim Panel Meeting - March 13, 2008
- Amgen to Discuss Romiplostim Application at FDA ODAC Meeting - March 12, 2008
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: 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: 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
FDA Drug Approvals Archive
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