FDA Drug Approvals

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

FDA Drug Approvals & Actions

Implanted Hearing System Approved To treat senorineural hearing loss	March 17, 2010
Pelvic Artery Stent Approved Props open vessel that supplies blood to the legs	March 12, 2010
Botox Approved for Spasticity in Stroke Victims A common aftereffect of stroke	March 9, 2010
Heartburn Drug Kapidex Renamed to Dexilant FDA approves name change to avoid confusion with other drugs	March 4, 2010
Generic Flomax Approved for Enlarged Prostate A common condition in older men	March 2, 2010
Replacement Therapy Approved for Gaucher Disease A rare genetic disorder	February 26, 2010
Extended-Release Mirapex Approved for Parkinson's Disease A once-daily treatment	February 24, 2010
Successor to Combination Pneumococcal Vaccine Approved Prevnar 13 offers broader protection against a host of bacterial diseases	February 24, 2010
Menveo Vaccine Approved for Bacterial Meningitis Among people aged 11 to 55	February 22, 2010
Rituxan Approved for Chronic Lymphocytic Leukemia A cancer of the blood and bone marrow	February 19, 2010
Benicar Approved for Kids With High Blood Pressure Ages 6 to 16	February 11, 2010
Crestor Approval Expanded For People Without High Cholesterol As a preventive for heart disease	February 9, 2010
Xiaflex Approved for Rare Hand Condition Dupuytren's contracture limits finger use	February 3, 2010
Approval Expanded for Breast Cancer Drug Tykerb To include certain postmenopausal women who need hormone therapy	February 1, 2010
Morphine Sulfate Solution Approved For acute and chronic pain	January 26, 2010
Victoza Sanctioned for Type 2 Diabetes But it may cause thyroid tumors and other side effects, FDA says	January 26, 2010
Heart Valve Implanted Via Catheter Approved Inserted by way of a tube in a leg vein and guided up to the heart	January 25, 2010
Ampyra Approved for Adults With MS Helps those who have trouble walking	January 22, 2010
Heart-Assist System Approved for Severe Heart Failure Among people who aren't candidates for heart transplant	January 20, 2010
Actemra Approved for Rheumatoid Arthritis For people who haven't responded to other RA drugs	January 11, 2010
Flu Vaccine for Seniors Approved A high-dose shot for people 65 and older	December 24, 2009
Spiriva Inhaler Approved To Reduce Flares of COPD Including chronic bronchitis and emphysema	December 18, 2009
Generic Aricept Approved for Alzheimer's Dementia Tablets dissolve on the tongue	December 16, 2009
Long-Acting Zyprexa Approved To treat adult schizophrenia	December 14, 2009
New Additive Aids Blood Platelet Storage InterSol approved for keeping platelets up to 5 days	December 10, 2009
Kalbitor Approved for Hereditary Angiodema A rare genetic condition	December 3, 2009
Zegerid OTC Approved for Frequent Heartburn In original prescription formula	December 2, 2009
Qutenza Approved for Post-Shingles Nerve Pain Active ingredient is found in chili peppers	November 17, 2009
Lysteda Approved for Heavy Menstrual Bleeding Designed to help blood to clot	November 16, 2009
Another Swine Flu Vaccine Approved for Children CSL's shot now for ages 6 months and older	November 13, 2009
Istodax Approved for Cutaneous T-Cell Lymphoma It's a disfiguring cancer affecting the skin	November 6, 2009
Arzerra Approved for Chronic Lymphocytic Leukemia Affects some 16,000 people annually	October 27, 2009
Votrient Approved for Advanced Kidney Cancer Designed to thwart blood vessel growth in tumors	October 20, 2009
Seasonal Flu Vaccine Approved for Children Fluarix sanctioned for kids aged 3 to 17	October 20, 2009
Micardis Given Wider Approval For cardiac patients who can't take an ACE inhibitor	October 19, 2009
Gardasil Approved to Prevent Genital Warts in Males Caused by human papillomavirus	October 19, 2009
Cervarix Approved to Help Prevent Cervical Cancer Vaccine blocks strains of human papilloma virus	October 16, 2009
Berinert Approved for Rare Genetic Disease To treats symptoms of hereditary angiodema	October 12, 2009
Folotyn Approved for Aggressive Type of Non-Hodgkin's Lymphoma For those who have relapsed or haven't responded to other therapies	September 25, 2009
Stelara Approved for Psoriasis Helps block overproduction of skin cells	September 25, 2009
Ovarian Cancer Test Approved Helps doctors decide on appropriate surgical options	September 11, 2009
Metozolv Approved for Diabetic Stomach Disorder, GERD But long-term use could cause serious side effects	September 8, 2009
Intuniv Approved for Pediatric ADHD No known potential for abuse, maker says	September 3, 2009
Valcyte Approved for Cytomegalovirus in Children A leading cause of infection in transplant patients	August 31, 2009
Zenpep Approved for Pancreatic Disorder Makes up for lack of digestive enzymes	August 28, 2009
Xyzal Approved for Younger Kids Antihistamine sanctioned for children as young as 6 months	August 25, 2009
Sabril Approved for Infantile Spasms In children ages 1 month to 2 years	August 21, 2009
New Hib Vaccine Granted Accelerated Approval To help remedy vaccine shortage	August 20, 2009
New Drug Approved for Gaucher Disease An inherited metabolic disorder	August 18, 2009
Extavia Approved for Multiple Sclerosis A type of interferon	August 17, 2009
Saphris Approved for Schizophrenia and Bipolar Disorder Two severe psychiatric illnesses	August 14, 2009
Livalo Approved for High Cholesterol A risk factor for heart disease	August 4, 2009
FDA Approves Avastin for Most Common Kidney Cancer In combination with a second drug	August 4, 2009
Sustained-Release Antipsychotic Approved for Schizophrenia Invega Sustenna injected once monthly	August 3, 2009
Colcrys Approved for Acute Gout, Mediterranean Fever Remedy long used to treat these two inflammatory conditions	July 31, 2009
Onglyza Sanctioned for Type 2 Diabetes A once-daily tablet to help control blood sugar	July 31, 2009
Onsolis Approved for Severe Cancer Pain Due to abuse risks, patch will be available under restricted distribution	July 16, 2009
Effient Sanctioned for Angioplasty Patients To reduce the risk of blood clots	July 10, 2009
Alimta Approved as Maintenance Therapy for Advanced Lung Cancer To prevent disease progression	July 6, 2009
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

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