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: 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
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: 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
FDA Drug Approvals Archive
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