FDA Drug Approvals

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

FDA Drug Approvals & Actions

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
FDA Approves Generic Risperdal Antipsychotic drug prescribed for schizophrenia	July 1, 2008
Device Helps Spinal Patients Breathe Without Ventilator Helps control diaphragm	June 18, 2008
Cymbalta Approved for Fibromyalgia Affects about 5 million Americans	June 16, 2008
Entereg Helps Restore Post-Operative Bowel Function After bowel resection surgery	May 21, 2008
New Laser Approved to Treat Psoriasis And other skin conditions	May 15, 2008
Amitiza Treats Irritable Bowel With Constipation Approved for women 18 and older	April 30, 2008
Device Approved to Assess Arterial Plaque Helps doctors evaluate heart attack risk	April 29, 2008
Relistor Helps Ease Painkiller-Related Constipation For people who use ongoing opioid therapy	April 25, 2008
Gloves Made From New Form of Latex Approved May benefit health workers, patients allergic to traditional latex	April 23, 2008
Cimzia Sanctioned to Treat Crohn's Disease For people who haven't responded to standard therapies	April 22, 2008
Compact Heart Assist Device Approved HeartMate II helps weakened heart for those awaiting transplant	April 21, 2008
Treximet Approved for Migraines Combines Imitrex and anti-inflammatory	April 18, 2008
Rotarix Approved to Treat Rotavirus in Children Germ causes gastroenteritis	April 4, 2008
Medical Adhesive Helps Burn Patients Artiss approved to attach skin grafts	March 20, 2008
Treanda Treats Rare Cancer Chemotherapy drug approved for chronic lymphocytic leukemia	March 20, 2008
Arcalyst Treats Rare Inflammatory Disorders Affecting 300 people in U.S.	February 29, 2008
Abilify Approved for Children With Bipolar Disorder Aged 10 to 17	February 29, 2008
GERD Drug Approved for Younger Children Ages 1 to 11	February 28, 2008
Humira Approved for Children's Arthritis In patients four years and older	February 22, 2008
Hemophilia Treatment Approved Xyntha supplements affected blood factor	February 21, 2008
'Decellularized' Heart Valve Approved A donated valve that's been stripped of human cells	February 7, 2008
Generic Versions of Fosamax Approved A popular drug to treat osteoporosis	February 6, 2008
Asmanex Approved for Asthmatic Children Inhaler may now be used by kids as young as 4 years	February 5, 2008
FDA Approves New Drug-Eluting Stent To help people with narrowed arteries	February 1, 2008
New HIV Drug Sanctioned When Others Fail Blocks enzyme that virus needs to multiply	January 31, 2008
Two-Drug Combination Approved for High Blood Pressure Eased hypertension better than either drug alone, maker says	January 21, 2008
New Test Screens For Flu and Other Viruses Said to be faster and more accurate than existing tests	January 21, 2008
Genetically Engineered Clotting Solution Approved To limit bleeding after surgery	January 18, 2008
Genetic Breast Cancer Test Approved Estimates likelihood of recurrence, overall survival	January 16, 2008
Sealant Helps Stem Bleeding During Surgery Helps blood clot when applied to small vessels	January 16, 2008
Tysabri Approved for Crohn's Disease Previously sanctioned for multiple sclerosis	January 15, 2008
14 New Blood-Typing Tests Approved To help ensure safe transfusions	January 11, 2008

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