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


FDA Drug Approvals & Actions

'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

Rapid Test for MRSA Approved
Quickly detects deadly staph bacterium

January 3, 2008

Voluven Helps Minimize Surgical Blood Loss
A 'blood volume expander'

December 27, 2007

Bystolic Approved for High Blood Pressure
A new drug to combat a 'silent killer'

December 18, 2007

Kuvan Sanctioned for PKU
A rare genetic disorder

December 13, 2007

Abilify Approved as Additional Treatment for Major Depression
When antidepressant therapy isn't enough

November 20, 2007

Nexavar Approved for Liver Cancer
Already sanctioned for advanced kidney cancer

November 19, 2007

Zyrtec-D Approved Without Prescription
Drug combines popular antihistamine and nasal decongestant

November 9, 2007

Abilify Approved for Adolescents With Schizophrenia
Sanctioned for adults in 2002

November 6, 2007

Combigan Drops Approved for Glaucoma
To treat pressure in the eye

October 31, 2007

Tasigna Approved for Chronic Myeloid Leukemia
For people resistant to other therapies

October 29, 2007

Voltaren Gel Approved for Osteoarthritis
First topical prescription treatment for the joint disease

October 22, 2007

Meningitis Vaccine Gets Expanded Approval
Age range for Menactra now includes children 2 to 10

October 22, 2007

New Drug Approved for Resistant HIV
Isentress inhibits enzyme that virus needs to multiply

October 17, 2007

Ixempra Approved for Breast Cancer
Targets protein that spurs growth of cancer cells

October 17, 2007

Hycamtin Approved for Relapsed Small Cell Lung Cancer
Available next year

October 15, 2007

Generic Anti-Seizure Drug Approved
Oxcarbazepine sanctioned for people 4 and older

October 10, 2007

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