FDA Drug Approvals
See also: Generic Approvals, New Drug Applications, Recent Additions to Drugs.com, Approval Process
Latest New Drug Approvals
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
Date of Approval: April 10, 2008
Company: CV Therapeutics, Inc.
Treatment for: Pharmacologic Stress Agent in Radionuclide Myocardial Perfusion Imaging
Lexiscan (regadenoson) is an A2A adenosine receptor agonist indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress.
- CV Therapeutics and Astellas Announce FDA Approval for Lexiscan (regadenoson) Injection - April 11, 2008
Date of Approval: April 3, 2008
Company: GlaxoSmithKline
Treatment for: Prevention of Rotavirus Gastroenteritis
Rotarix is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.
- FDA Approves Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus - April 4, 2008
- GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral) - February 20, 2008
- GlaxoSmithKline's Application for Rotarix is Accepted for Review by the FDA - August 14, 2007
- AVANT's Partner, GlaxoSmithKline, Files Rotarix Application for U.S. Marketing Approval with the FDA - June 27, 2007
Date of Approval: March 20, 2008
Company: Cephalon, Inc.
Treatment for: Chronic Lymphocytic Leukemia
Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL).
- Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapy for Chronic Lymphocytic Leukemia - March 20, 2008
- FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma - February 19, 2008
- Cephalon Submits New Drug Application for Treanda for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma - January 2, 2008
- Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA - December 3, 2007
- Cephalon Submits New Drug Application for Treanda for the Treatment of Chronic Lymphocytic Leukemia - September 21, 2007
- Cephalon Announces Plans for New NDA Filing for Treanda - June 28, 2007
Date of Approval: March 19, 2008
Company: Baxter Healthcare Corporation
Treatment for: Burns - External
Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients.
- FDA Approves Artiss Medical Adhesive to Treat Burn Patients - March 19, 2008
Date of Approval: March 7, 2008
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Folic Acid Antagonist Overdose, Methotrexate Rescue
Levoleucovorin is a folate analog and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin rescue is used after the administration of high-dose methotrexate in osteosarcoma. Levoleucovorin is also used to treat inadvertent overdosage of folic acid antagonists.
- FDA Approves New Drug Application for Levoleucovorin, Spectrum's First Proprietary Oncology Drug - March 10, 2008
- FDA Accepts ISO-Vorin New Drug Application Amendment Submitted by Spectrum Pharmaceuticals - September 13, 2007
- Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin - July 2, 2007
Date of Approval: February 29, 2008
Company: Wyeth Pharmaceuticals
Treatment for: Depression
Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.
- FDA Approves Pristiq for the Treatment of Adult Patients with Major Depressive Disorder - March 3, 2008
- Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause - July 24, 2007
- Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder - January 23, 2007
- Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate - August 29, 2006
- FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder - August 22, 2006
- Wyeth Submits Two New Drug Applications for Women's Health Therapies - June 26, 2006
- Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression - December 22, 2005
Date of Approval: February 27, 2008
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes
Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
- FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) - February 28, 2008
- PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA - November 2, 2007
- Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS - August 8, 2007
- Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS - June 8, 2007
Date of Approval: February 21, 2008
Company: Wyeth Pharmaceuticals Inc.
Treatment for: Hemophilia A
Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.
- FDA Licenses Xyntha, a New Hemophilia Treatment - February 21, 2008
FDA Drug Approvals Archive
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