FDA Drug Approvals

Saint Luke's Health System Health Resource Center

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

FDA Drug Approvals & Actions

Flu Vaccine for Upcoming Season Approved Protects against three strains predicted to be most prevalent	July 30, 2010
Cuvposa Approved for Chronic Drooling in Children Primarily those with neurological disorders	July 29, 2010
Combination Drug Approved for High Blood Pressure Tribenzor sanctioned for those who don't respond to other drugs	July 26, 2010
Generic Lovenox Approved for Deep Vein Thrombosis A condition that could cause deadly blood clots	July 23, 2010
'Miniature Telescope' for Eye Approved for Macular Degeneration Implanted device replaces eye's natural lens	July 6, 2010
Generic Effexor XR Approved To treat major depressive disorder	June 29, 2010
Rapid Test to Detect Hepatitis C Approved OraQuick HCV can detect viral antibodies in about 20 minutes	June 25, 2010
Dulera Inhaler Approved for Asthma For people 12 and older	June 24, 2010
Newly Approved HIV Test Can Spot Infection Earlier Detects both HIV antigen and antibodies	June 21, 2010
Tasigna Approval Widened to Include Early Stages of Rare Leukemia But users are at greater risk of heart disorder	June 18, 2010
Jevtana Approved for Advanced Prostate Cancer When disease continues to worsen after treatment with standard drug	June 17, 2010
Prolia Approved for Post-Menopausal Women With Osteoporosis Injectable drug given once every 6 months	June 2, 2010
Lumizyme Approved for Non-Infantile Pompe Disease A rare genetic disorder	May 25, 2010
Simplexa H1N1 Test Approved Detects 'swine flu' infection	May 24, 2010
Sprix Approved for Moderate-to-Severe Pain A non-narcotic nasal spray	May 17, 2010
New Parasite Screening Test Approved For donated blood, tissue and organs	May 3, 2010
Provenge Approved for Advanced Prostate Cancer Helps immune system combat the disease	April 29, 2010
Radiofrequency Device Approved for Severe Chronic Asthma Helps control lung inflammation	April 28, 2010
Pancreaze Approved for Lack of Pancreatic Enzymes 200,000 in U.S. need such products	April 13, 2010
First Generic Versions of Cozaar and Hyzaar Approved Drugs to treat high blood pressure	April 8, 2010
Tougher-to-Abuse Form of OxyContin Approved These pills are harder to cut and dissolve, maker says	April 6, 2010
TachoSil Sealant Patch Approved for Cardiovascular Surgery Prevents bleeding from small vessels	April 5, 2010
Asclera Approved to Treat Varicose Veins Improves appearance of swollen or twisted blood vessels	March 31, 2010
Zyclara Approved to Treat Pre-Cancerous Skin Condition Some 10 million Americans have actinic keratoses	March 26, 2010
Xifaxan Approved for People With Liver Disease To treat disorder that affects brain function	March 25, 2010
Carbaglu Approved for Rare Genetic Disorder Causes elevated ammonia in blood	March 18, 2010
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
Another Swine Flu Vaccine Approved for Children CSL's shot now for ages 6 months and older	November 13, 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

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