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Headlines Archive

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


FDA Drug Approvals & Actions

Gleevec Approval Widened to Include Rare Cancer
CD117-positive gastrointestinal stromal tumors

February 1, 2012

Kalydeco Approved to Treat Rare Form of Cystic Fibrosis
First drug to target underlying cause of chronic disease

January 31, 2012

Erivedge Approved to Treat Basal Cell Carinoma
The most common skin cancer

January 30, 2012

Drug Approved for Advanced Kidney Cancer
Inlyta is for people who don't respond to another drug

January 27, 2012

Bydureon Approved for Type 2 Diabetes
A once-weekly injection

January 27, 2012

First Test Approved to Help Detect Risk of Rare Brain Infection
Among users of the drug Tysabri

January 20, 2012

Voraxaze Approved to Treat High Levels of Chemo Drug
Blood amounts can rise due to kidney failure

January 18, 2012

Endovascular Graft Approved for Tears of Aorta
The body's largest artery

January 16, 2012

Pneumonia Vaccine Approved for Older People
Prevnar 13 shot sanctioned for people 50 and up

January 3, 2012

Isentress Approval Expanded to Include Children and Teens
To combat AIDS-causing virus

December 21, 2011

Edarbyclor Approved for High Blood Pressure
Condition affects about 1 in 3 Americans

December 20, 2011

New Device Approved for Children With Heart Failure
To be used until donor heart can be found

December 16, 2011

First Generic Lipitor Approved
Widely used statin drug helps lower bad cholesterol

December 1, 2011

Erwinaze Approved for Acute Lymphoblastic Leukemia
A rare form of blood cancer

November 18, 2011

Jakafi Approved for Rare Bone-Marrow Disease
First drug in U.S. sanctioned for myelofibrosis

November 16, 2011

FDA Approves First Umbilical Cord Blood Product
Hemacord stem cell product sanctioned for certain blood cancers and related disorders

November 11, 2011

Erbitux Approval Expanded to Include Head and Neck Cancer
Most common in men, people older than 50

November 7, 2011

Xarelto Approved to Prevent Stroke in People With Abnormal Heartbeat
Atrial fibrillation affects more than 2 million Americans

November 4, 2011

Artificial Heart Valve Doesn't Require Open-Heart Surgery
Implanted via catheter

November 3, 2011

MelaFind Device Approved to Detect Melanoma
A deadly form of skin cancer

November 2, 2011

Device Approved to Remedy Abdominal Aneurysms
In people with smaller arteries

November 2, 2011

Exparel Approved for Post-Surgery Pain
Provides relief up to 72 hours

October 31, 2011

Onfi Approved to Treat Severe Seizures
When combined with other anti-seizure medication

October 24, 2011

First Versions of Generic Zyprexa Approved
To treat schizophrenia or bipolar disorder

October 24, 2011

Ferriprox Approved to Treat 'Iron Overload'
A potential problem among people who get frequent blood transfusions

October 14, 2011

Cialis Approved to Treat Enlarged Prostate
Also approved for treatment of BPH and erectile dysfunction occurring simultaneously

October 7, 2011

Juvisync Approved for Type 2 Diabetics With High Cholesterol
Previously approved meds combined in one tablet

October 7, 2011

'LeGoo' Vessel Plug Approved for Vascular Surgery
Dissolvable gel stems blood flow while joining vessels

October 4, 2011

Child Face Mask Approved to Help Prevent Spread of Germs
In hospitals and other health care settings

September 28, 2011

Remicade Approved for Ulcerative Colitis in Children
Aged six and older

September 26, 2011

Soliris Approval Expanded to Include Rare Blood Disorder
Drug first approved in 2007

September 23, 2011

FDA OKs Bone Drug to Prevent Fracture in Certain Cancer Patients
Prolia can be used in some cases of prostate cancer and breast cancer

September 19, 2011

Flu Diagnostic Kit Approved
Developed by the CDC

September 2, 2011

Xalkori Approved for Advanced Lung Cancer
Therapy targets abnormal gene

August 29, 2011

Extended-release Painkiller Approved
Nucynta ER sanctioned for chronic pain in adults

August 26, 2011

Firazyr Approved for Rare Swelling Disease
Hereditary angiodema can cause tissue in limbs, airway to swell

August 25, 2011

Adcetris Approved to Treat Lymphomas
New treatment fights cancers of the lymphatic system

August 19, 2011

New Drug Approved for Advanced Skin Cancer
Companion test also sanctioned to detect certain melanoma cells

August 17, 2011

First Treatment Solely for Scorpion Stings Approved
Poisonous arthropods found mostly in Arizona

August 4, 2011

Brilinta Approved for Acute Coronary Syndromes
Blood-thinning drug helps prevent clotting

July 21, 2011

Flu Vaccine for 2011-12 Season Approved
Protects against strains predicted to be most prevalent

July 18, 2011

Boostrix Approved to Prevent Tetanus, Diphtheria and Whooping Cough in Seniors
First single vaccine to prevent all 3 diseases in elderly

July 11, 2011

Arcapta Inhaler Approved for COPD
Helps prevent wheezing and shortness of breath

July 5, 2011

Lazanda Approved for Cancer Pain
Painkiller fentanyl produced in nasal spray form

July 1, 2011

Abuse-Resistant Oxycodone Approved
Oxecta ingredient discourages extra doses

June 20, 2011

Generic Versions of Levofloxacin Approved
Antibiotic prescribed for infections of sinuses, kidneys or bladder

June 20, 2011

Nulojix Approved to Help Thwart Kidney Rejection
For adults who have had kidney transplant

June 16, 2011

New Test Helps Evaluate Breast Cancer Patients for Herceptin Use
Screens cells for copies of HER2 gene

June 14, 2011

First Ceramic-on-Metal Hip Replacement Approved
For people with osteoarthritis

June 14, 2011

Potiga Approved for Adult Epileptic Seizures
But drug may cause 'neuro-psychiatric' side effects, FDA says

June 13, 2011

New Device Performs Body Scans Simultaneously
Reducing overall radiation

June 10, 2011

Dificid Approved to Treat C. diff Diarrhea
Bacterial infection commonly acquired in hospitals

May 31, 2011

Solesta Gel Approved for Fecal Incontinence
A condition affecting 5.5 million Americans

May 31, 2011

Sutent Approved for Rare Pancreatic Cancer
For inoperable or spreading tumors

May 23, 2011

Incivek Approved for Hepatitis C
Among people who haven't received or responded to standard interferon

May 23, 2011

Edurant Approved To Treat AIDS Virus
In combination with other antiretroviral drugs

May 20, 2011

New Test Sanctioned to Detect Q Fever in Overseas Soldiers
Such as those serving in Iraq

May 20, 2011

New Test Detects Recent Infection With Toxoplasmosis
Parasite dangerous to pregnant women

May 19, 2011

Victrelis Approved for Chronic Hepatitis C
In combination with two other drugs

May 16, 2011

Afinitor Approved for Rare Pancreatic Cancer
Extended survival in clinical studies

May 6, 2011

FDA Sanctions Wider Use of Carotid Stent
For people with clogged neck artery

May 6, 2011

FDA OK's Test to Spot Drug-Resistant Staph
Just-approved diagnostic identifies MRSA infections

May 6, 2011

Tradjenta Approved for Type 2 Diabetes
The disease's most common form

May 2, 2011

Zytiga Approved for Advanced Prostate Cancer
FDA: Improved patient survival shown in clinical testing

April 29, 2011

Approval for Meningitis Vaccine Expanded to Include Toddlers
As young as 9 months

April 25, 2011

Device Approved to Treat Brain Aneurysm
A weakened bulge in an artery

April 14, 2011

New RX for Large Brain Aneurysm
Treatment for bulge in an artery wall

April 13, 2011

1st U.S. Test to Diagnose Dengue Fever Approved
Illness more common in Latin America, Caribbean and Asia

April 11, 2011

FDA OKs Rapid Test to Spot Dangerous Intestinal Infection
C. difficile is commonly acquired in hospitals

April 8, 2011

Vandetanib Approved for a Rare Thyroid Cancer
Designed to extend survival in patients with late-stage disease

April 7, 2011

Horizant Approved to Treat Restless Legs Syndrome
Possible side effects include drowsiness and dizziness

April 7, 2011

Nerve Stimulation Device Approved to Restore Bowel Control
For people with chronic fecal incontinence

April 4, 2011

Just-Approved Defibrillators Limit Unnecessary Shocks
Medtronic devices said to recognize irregular heartbeat that's life-threatening

March 29, 2011

Drug Approved for Late-Stage Melanoma
Yervoy fights deadly form of skin cancer, agency says

March 25, 2011

U.S. Shingles Vaccine Approval Expanded
To include people in their 50s

March 24, 2011

Gadavist Approved to Enhance Nervous System Imaging
A contrast agent for certain MRIs

March 15, 2011

Device Approved to Continue Blood Flow During Brain Surgery
Among patients at greater risk of stroke

March 11, 2011

Benlysta Approved for Lupus
Last-approved lupus drug sanctioned 56 years ago

March 10, 2011

Roflumilast Approved for Form of COPD
Drug aimed at treating lung disease characterized by chronic bronchitis

March 1, 2011

Edarbi Approved for High Blood Pressure
But shouldn't be taken by pregnant women

February 28, 2011

Corifact Approved for Genetic Bleeding Disorder
Made from donated plasma

February 18, 2011

People Who Weigh Less Now Qualify for Gastric Device
Under new approval, Lap-Band system can now be used by less obese

February 17, 2011

First 3-D Mammography Test Cleared
To help screen for breast cancer

February 11, 2011

Test Approved to Monitor Levels of Kidney Rejection Drug
Too much of the drug in blood may be toxic

February 11, 2011

MRI-Friendly Pacemaker Approved
System designed to work with magnetic resonance imaging devices

February 8, 2011

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