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


FDA Drug Approvals & Actions

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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