New Drug Approvals
The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.
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: July 1, 2009
Company: Sanofi-aventis
Treatment for: Atrial Fibrillation, Atrial Flutter
Multaq (dronedarone) is antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter.
- FDA Approves Multaq for Patients with Atrial Fibrillation or Atrial Flutter - July 2, 2009
- FDA Advisory Committee Recommends Approval of Multaq (dronedarone) - March 19, 2009
- Multaq (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation - August 8, 2008
Date of Approval: June 30, 2009
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure
Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
- FDA Approves Feraheme to Treat Iron Deficiency Anemia in Adult Chronic Kidney Disease Patients - June 30, 2009
- AMAG Pharmaceuticals Announces New PDUFA Date for Feraheme (ferumoxytol injection) - May 12, 2009
- AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol - December 23, 2008
- AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA - November 13, 2008
- AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol - October 20, 2008
- AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease - February 19, 2008
- AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients - December 19, 2007
Date of Approval: June 17, 2009
Company: Kowa Pharmaceuticals America, Inc.
Treatment for: Migraine
Cambia (diclofenac potassium) is a non-steroidal anti-inflammatory drug combined with potassium bicarbonate for the treatment of acute migraine with or without aura in adults.
- FDA Approves Cambia for Migraine - June 23, 2009
- ProEthic Pharmaceuticals Announces Acceptance of PRO-513 New Drug Application for Migraine - December 12, 2007
Date of Approval: June 17, 2009
Company: Allergan, Inc.
Ozurdex (dexamethasone intravitreal implant) is a sustained-release, potent steroid implant for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
- Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease - June 18, 2009
Date of Approval: June 18, 2009
Company: Novartis AG
Treatment for: Cryopyrin-Associated Periodic Syndrome
Ilaris (canakinumab) is a human monoclonal antibody for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS).
- New Biological Therapy Ilaris Approved In US To Treat Children And Adults With CAPS, A Serious Life-Long Auto-Inflammatory Disease - June 18, 2009
Date of Approval: June 16, 2009
Company: Xanodyne Pharmaceuticals, Inc.
Treatment for: Pain
Zipsor is a rapid release diclofenac potassium formulation for the treatment of patients with mild to moderate acute pain.
- Xanodyne Receives Approval From the U.S. Food and Drug Administration for Zipsor (diclofenac potassium) Liquid Filled Capsules - June 17, 2009
- Xanodyne Receives Approvable Letter From the FDA for Zipsor Capsules - July 22, 2008
Date of Approval: June 11, 2009
Company: Cumberland Pharmaceuticals
Treatment for: Pain, Fever
Caldolor is an intravenous formulation of ibuprofen indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults.
- Cumberland Pharmaceuticals Announces FDA Approval of Caldolor - June 12, 2009
Date of Approval: May 28, 2009
Company: Bausch & Lomb
Treatment for: Bacterial Conjunctivitis
Besivance (besifloxacin ophthalmic suspension) is a topical quinolone antimicrobial for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye."
- Bausch & Lomb Receives FDA Approval of Besivance, New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') - May 29, 2009
- FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop - December 5, 2008
Date of Approval: May 22, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension
Adcirca (tadalafil) is a once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).
- FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension - May 26, 2009
Date of Approval: May 19, 2009
Company: Otsuka Pharmaceutical Development & Commercialization, Inc.
Treatment for: Hyponatremia
Samsca (tolvaptan) is an oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia.
- FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia - May 22, 2009
- U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia - June 26, 2008
- New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration - December 21, 2007
Date of Approval: May 6, 2009
Company: Vanda Pharmaceuticals Inc.
Treatment for: Schizophrenia
Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia.
- FDA Approves Fanapt to Treat Schizophrenia - May 7, 2009
- FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date - November 20, 2008
- Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone - July 28, 2008
- Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application - November 27, 2007
- Vanda Pharmaceuticals Submits Iloperidone New Drug Application - September 27, 2007
Date of Approval: May 5, 2009
Company: VeroScience and S2 Therapeutics, Inc.
Treatment for: Diabetes Mellitus Type II
Cycloset (bromocriptine) is a first-in-class, central acting agent for the treatment of Type 2 Diabetes.
Date of Approval: April 30, 2009
Company: Solvay Pharmaceuticals, Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Creon (pancrelipase) is a pancreatic enzyme preparation for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions.
Date of Approval: May 1, 2009
Company: Salvat
Treatment for: Otitis Externa
Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa.
- FDA Approves Cetraxal Otic Solution - May 1, 2009
- Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal - November 6, 2008
- Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution - September 14, 2005
- SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis - June 10, 2005
- Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis - April 18, 2005
Date of Approval: April 30, 2009
Company: Novartis AG
Treatment for: Hypertension
Exforge HCT is a combination of the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide indicated for the once-daily combination treatment of hypertension.
- FDA approves Exforge HCT - the only high blood pressure treatment to combine three medications in a single pill - April 30, 2009
Date of Approval: April 30, 2009
Company: Medicis and Ipsen
Treatment for: Cervical Dystonia, Glabellar Lines
Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent for the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and for the temporary improvement in the appearance of moderate to severe glabellar lines.
- FDA Approves Dysport for Therapeutic and Aesthetic Uses - April 30, 2009
- FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application - December 29, 2008
- Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport in Cervical Dystonia - January 31, 2008
- Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport - December 6, 2007
Date of Approval: April 24, 2009
Company: Centocor, Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody administered once-monthly for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
- Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis - April 24, 2009
- Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis - June 27, 2008
Date of Approval: April 9, 2009
Company: Sciele Pharma, Inc.
Treatment for: Lice
Benzyl Alcohol Lotion 5% is a non-toxic, insecticide-free head lice treatment which prevents lice from closing their spiracles (sophisticated breathing apparatus) thereby killing the lice by asphyxiation.
- Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment - April 13, 2009
- Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment - July 16, 2008
- Sciele Provides Update on Head Lice Asphyxiation Product - February 20, 2008
- Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment - August 16, 2007
Date of Approval: April 7, 2009
Company: Novartis
Treatment for: Malaria
Coartem (artemether and lumefantrine) is an artemisinin-based combination treatment for the treatment of malaria.
- Coartem receives FDA approval becoming first artemisinin-based combination treatment (ACT) for malaria in the US - April 8, 2009
Date of Approval: March 30, 2009
Company: Intercell AG
Treatment for: Japanese Encephalitis Virus Prophylaxis
Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis.
- Intercell Announces FDA Approval of Ixiaro, a Novel Vaccine to Prevent Japanese Encephalitis - March 31, 2009
- Intercell making strides towards imminent approval of its Japanese Encephalitis vaccine in the United States –Approvals in United States, Europe and Australia remain on track for 2008 - October 21, 2008
FDA Drug Approvals Archive
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