FDA Drug Approvals

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

FDA Drug Approvals & Actions

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
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

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