FDA Drug Approvals

FDA Approvals and Actions
Drug approvals, recalls and actions by the Food and Drug Administration.

FDA Drug Approvals & Actions

Multaq Sanctioned for Heart Rhythm Disorders Atrial fibrillation or atrial flutter	July 2, 2009
Ozurdex Implant Approved for Macular Edema When cause is blocked vein, doctors have a new therapy to offer	June 18, 2009
Caldolor Is First Approved Injected Ibuprofen For hospital patients who can't take oral drug	June 12, 2009
New Drug Fights Cancer in Dogs Palladia approved to treat dangerous skin tumors	June 3, 2009
Besivance Approved for Bacterial Conjunctivitis Contagious condition often called 'pink eye'	May 29, 2009
Ankle Replacement Device Approved For people with deformed or arthritic joint	May 28, 2009
Adcirca Approved for Lung Disorder Drug has the same active ingredient as Cialis	May 26, 2009
Fanapt Sanctioned for Schizophrenia But FDA warns against off-label use	May 7, 2009
Avastin Gets New Approval for Brain Cancer Of the type affecting Senator Kennedy	May 7, 2009
Creon, a Pancreatic Enzyme Substitute, Approved Derived from pig pancreas	May 7, 2009
Cycloset Approved for Type 2 Diabetes Helps control blood sugar via the brain	May 6, 2009
Dysport, a Botox Competitor, Approved Derived from botulinum toxin	April 30, 2009
Simponi Approved for Immune-Related Arthritis A drug injected monthly	April 24, 2009
Benzyl Alcohol Lotion Approved for Head Lice In people 6 months and older	April 10, 2009
Rapid Test to Detect Bird Flu in People Approved Results available in less than 40 minutes	April 8, 2009
Coartem Approved to Treat Malaria U.S. travelers to stricken areas are at risk of infection	April 8, 2009
Vaccine Approved for Japanese Encephalitis Mosquito-borne virus strikes mostly in Asia	March 31, 2009
Afinitor Approved for Advanced Kidney Cancer When cancer progresses despite other treatments	March 30, 2009
Symbyax Approved for Treatment-Resistant Depression For people who don't respond to other antidepressants	March 23, 2009
Lexapro Approved for Adolescent Depression For people aged 12 to 17 with major depressive disorder	March 20, 2009
First DNA Tests for HPV Approved The virus associated with most cases of cervical cancer	March 13, 2009
Second-Generation Female Condom Approved Protects against pregnancy and sexually transmitted disease	March 11, 2009
Device Approved for Child Heart Operations Helps minimize scarring after surgery	March 9, 2009
Solostar Injection Pen Approved for Diabetes Prefilled with Apidra, a rapid-acting insulin	February 26, 2009
Implanted Device Approved for Severe Obsessive-Compulsive Disorder Reclaim device delivers electrical stimulation to the brain	February 19, 2009
Uloric Approved for Gout The first new treatment option in 40 years	February 16, 2009
1st Drug From Genetically Altered Animals Approved ATryn sanctioned for rare genetic blood disorder	February 9, 2009
First Ablation Catheters Approved for Atrial Fibrillation Designed to treat irregular heartbeat when medication doesn't work	February 6, 2009
Vectical Ointment Approved for Psoriasis Vitamin D3 is active ingredient	February 4, 2009
Kapidex Approved for Acid Reflux A reformulated version of Prevacid	February 2, 2009
Gelnique Approved for Overactive Bladder A topical gel for treating symptoms	January 28, 2009
Riastap Approved for Rare Blood Disorder Congenital fibrinogen deficiency can cause uncontrolled bleeding	January 16, 2009
Savella Approved for Fibromyalgia Expected in pharmacies by March	January 15, 2009
Diagnostic Approved to Detect C. diff An infection commonly acquired in hospitals	January 13, 2009
Nucleic Acid Test Screens for HIV In donated blood and tissue	December 31, 2008
Degarelix Approved for Advanced Prostate Cancer Suppresses testosterone production	December 29, 2008
Gleevec Approved for Use After Cancer Surgery Drug first sanctioned in 2001	December 22, 2008
Zolpimist Approved for Insomnia Oral spray contains Ambien's active ingredient	December 22, 2008
Mozobil Boosts Stem Cells Before Bone Marrow Transplants Could help people with certain forms of blood cancer	December 19, 2008
TriLipix Approved to Help Lower Cholesterol To be used alone, or in combination with a statin	December 16, 2008
Promacta Approved for Rare Blood Disorder Affects about 60,000 people in United States	November 24, 2008
Banzel Approved for Lennox-Gastaut Syndrome A severe form of epilepsy	November 21, 2008
Ontak Approved to Treat T-Cell Lymphoma Targets specific receptor on cancer cells	October 17, 2008
NeuroStar Depression Therapy Cleared Targets nerve cells with magnetic pulses	October 13, 2008
Kogenate FS Prevents Joint Damage in Young Hemophiliacs Hemophilia A affects about 15,000 in the U.S.	October 10, 2008
Rapaflo Approved for Enlarged Prostate The leading reason men visit urologists	October 9, 2008
'Superbug' Test Detects MRSA Faster Existing diagnostics can take up to 3 days	September 29, 2008
Anti-Nausea Patch Approved for Chemo Patients Protects for up to 5 days	September 18, 2008
Gardasil Approved for Additional Uses To help protect women against two more cancers	September 15, 2008
Keppra XR Approved for Partial-Onset Seizures For people 16 and older	September 15, 2008
New Test Identifies Heart Transplant Rejection Monitors gene activity in white blood cells	August 27, 2008
Bone Marrow Treatment Approved for Rare Bleeding Disorder Stimulates marrow to compensate for low platelet count	August 22, 2008
First Treatment Sanctioned for Chorea in Huntington's Patients The involuntary jerky movements that accompany the disease	August 15, 2008
Viread Approved for Hepatitis B Already sanctioned to treat HIV	August 12, 2008
Injected Drug Approved for High Blood Pressure When oral therapy isn't feasible	August 4, 2008
New Test IDs Cancer Cells in Tumors Helps pinpoint which type of cancer is present	July 31, 2008
First Generic Versions of Depakote Approved To treat seizures, migraines, and bipolar disorder	July 29, 2008
Breast Cancer Test Rates Drug Therapy Candidates Helps doctors make better treatment decisions	July 8, 2008
New 5-in-1 Vaccine May Reduce Number of Pediatric Shots By as many as one-third	June 23, 2008
1st U.S. Drug Approved for Fibromyalgia Millions have the painful condition	June 21, 2007

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