Drug Approvals Information from the FDA

February 26, 2010

Replacement Therapy Approved for Gaucher Disease

A rare genetic disorder

MONDAY, Feb. 16 (HealthDay News) -- Takeda Pharmaceuticals' Uloric (febuxostat) has been approved by the U.S. Food and Drug Administration to treat gout, a painful condition characterized by elevated levels of uric acid that can build up in the blood, joints and soft tissue.

Uloric is the first new treatment option in more than four decades for gout, a chronic condition affecting more than 5 million Americans, the Japanese drug maker said in a news release. It's the most common inflammatory arthritis in men 40 and older.

The FDA approved the drug in 40 mg. and 80 mg. strengths. Takeda initially requested approval for 80 mg. and 120 mg versions, but the agency was concerned about possible cardiovascular side effects stemming from the higher doses, the Bloomberg news service reported.

Uloric was evaluated in clinical trials involving more than 4,000 people. The most common side effects reported were liver function abnormalities, nausea, joint pain and rash.

More information

The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about gout.

February 24, 2010

Successor to Combination Pneumococcal Vaccine Approved

Prevnar 13 offers broader protection against a host of bacterial diseases

View FDA Statement

February 24, 2010

Extended-Release Mirapex Approved for Parkinson's Disease

A once-daily treatment

View FDA Statement

February 22, 2010

Menveo Vaccine Approved for Bacterial Meningitis

Among people aged 11 to 55

View FDA Statement

February 19, 2010

Rituxan Approved for Chronic Lymphocytic Leukemia

A cancer of the blood and bone marrow

View FDA Statement

February 11, 2010

Benicar Approved for Kids With High Blood Pressure

Ages 6 to 16

View FDA Statement

February 9, 2010

Crestor Approval Expanded For People Without High Cholesterol

As a preventive for heart disease

View FDA Statement

February 3, 2010

Xiaflex Approved for Rare Hand Condition

Dupuytren's contracture limits finger use

View FDA Statement

February 1, 2010

Approval Expanded for Breast Cancer Drug Tykerb

To include certain postmenopausal women who need hormone therapy

View FDA Statement

January 26, 2010

Victoza Sanctioned for Type 2 Diabetes

But it may cause thyroid tumors and other side effects, FDA says

View FDA Statement

January 26, 2010

Morphine Sulfate Solution Approved

For acute and chronic pain

View FDA Statement

January 25, 2010

Heart Valve Implanted Via Catheter Approved

Inserted by way of a tube in a leg vein and guided up to the heart

View FDA Statement

January 22, 2010

Ampyra Approved for Adults With MS

Helps those who have trouble walking

View FDA Statement

January 20, 2010

Heart-Assist System Approved for Severe Heart Failure

Among people who aren't candidates for heart transplant

View FDA Statement

January 11, 2010

Actemra Approved for Rheumatoid Arthritis

For people who haven't responded to other RA drugs

View FDA Statement

December 24, 2009

Flu Vaccine for Seniors Approved

A high-dose shot for people 65 and older

View FDA Statement

December 18, 2009

Spiriva Inhaler Approved To Reduce Flares of COPD

Including chronic bronchitis and emphysema

View FDA Statement

December 16, 2009

Generic Aricept Approved for Alzheimer's Dementia

Tablets dissolve on the tongue

View FDA Statement

December 14, 2009

Long-Acting Zyprexa Approved

To treat adult schizophrenia

View FDA Statement

December 10, 2009

New Additive Aids Blood Platelet Storage

InterSol approved for keeping platelets up to 5 days

View FDA Statement

December 3, 2009

Kalbitor Approved for Hereditary Angiodema

A rare genetic condition

View FDA Statement

December 2, 2009

Zegerid OTC Approved for Frequent Heartburn

In original prescription formula

View FDA Statement

November 17, 2009

Qutenza Approved for Post-Shingles Nerve Pain

Active ingredient is found in chili peppers

View FDA Statement

November 16, 2009

Lysteda Approved for Heavy Menstrual Bleeding

Designed to help blood to clot

View FDA Statement

November 13, 2009

Another Swine Flu Vaccine Approved for Children

CSL's shot now for ages 6 months and older

View FDA Statement

November 6, 2009

Istodax Approved for Cutaneous T-Cell Lymphoma

It's a disfiguring cancer affecting the skin

View FDA Statement

October 27, 2009

Arzerra Approved for Chronic Lymphocytic Leukemia

Affects some 16,000 people annually

View FDA Statement

October 20, 2009

Seasonal Flu Vaccine Approved for Children

Fluarix sanctioned for kids aged 3 to 17

View FDA Statement

October 20, 2009

Votrient Approved for Advanced Kidney Cancer

Designed to thwart blood vessel growth in tumors

View FDA Statement

October 19, 2009

Gardasil Approved to Prevent Genital Warts in Males

Caused by human papillomavirus

View FDA Statement

October 19, 2009

Micardis Given Wider Approval

For cardiac patients who can't take an ACE inhibitor

View FDA Statement

October 16, 2009

Cervarix Approved to Help Prevent Cervical Cancer

Vaccine blocks strains of human papilloma virus

View FDA Statement

October 12, 2009

Berinert Approved for Rare Genetic Disease

To treats symptoms of hereditary angiodema

View FDA Statement

September 25, 2009

Stelara Approved for Psoriasis

Helps block overproduction of skin cells

View FDA Statement

September 25, 2009

Folotyn Approved for Aggressive Type of Non-Hodgkin's Lymphoma

For those who have relapsed or haven't responded to other therapies

View FDA Statement

September 11, 2009

Ovarian Cancer Test Approved

Helps doctors decide on appropriate surgical options

View FDA Statement

September 8, 2009

Metozolv Approved for Diabetic Stomach Disorder, GERD

But long-term use could cause serious side effects

View FDA Statement

September 3, 2009

Intuniv Approved for Pediatric ADHD

No known potential for abuse, maker says

View FDA Statement

August 31, 2009

Valcyte Approved for Cytomegalovirus in Children

A leading cause of infection in transplant patients

View FDA Statement

August 28, 2009

Zenpep Approved for Pancreatic Disorder

Makes up for lack of digestive enzymes

View FDA Statement

August 25, 2009

Xyzal Approved for Younger Kids

Antihistamine sanctioned for children as young as 6 months

View FDA Statement

August 21, 2009

Sabril Approved for Infantile Spasms

In children ages 1 month to 2 years

View FDA Statement

August 20, 2009

New Hib Vaccine Granted Accelerated Approval

To help remedy vaccine shortage

View FDA Statement

August 18, 2009

New Drug Approved for Gaucher Disease

An inherited metabolic disorder

View FDA Statement

August 17, 2009

Extavia Approved for Multiple Sclerosis

A type of interferon

View FDA Statement

August 14, 2009

Saphris Approved for Schizophrenia and Bipolar Disorder

Two severe psychiatric illnesses

View FDA Statement

August 4, 2009

FDA Approves Avastin for Most Common Kidney Cancer

In combination with a second drug

View FDA Statement

August 4, 2009

Livalo Approved for High Cholesterol

A risk factor for heart disease

View FDA Statement

August 3, 2009

Sustained-Release Antipsychotic Approved for Schizophrenia

Invega Sustenna injected once monthly

View FDA Statement

July 31, 2009

Onglyza Sanctioned for Type 2 Diabetes

A once-daily tablet to help control blood sugar

View FDA Statement

July 31, 2009

Colcrys Approved for Acute Gout, Mediterranean Fever

Remedy long used to treat these two inflammatory conditions

View FDA Statement

July 24, 2009

Forteo Approved for Drug-Related Osteoporosis

For people taking glucocorticoid medications

View FDA Statement

July 20, 2009

Seasonal Flu Vaccine Approved

But it won't protect against swine flu

View FDA Statement

July 16, 2009

Onsolis Approved for Severe Cancer Pain

Due to abuse risks, patch will be available under restricted distribution

View FDA Statement

July 10, 2009

Effient Sanctioned for Angioplasty Patients

To reduce the risk of blood clots

View FDA Statement

July 6, 2009

Alimta Approved as Maintenance Therapy for Advanced Lung Cancer

To prevent disease progression

View FDA Statement

July 2, 2009

Multaq Sanctioned for Heart Rhythm Disorders

Atrial fibrillation or atrial flutter

View FDA Statement

June 18, 2009

Ozurdex Implant Approved for Macular Edema

When cause is blocked vein, doctors have a new therapy to offer

View FDA Statement

June 12, 2009

Caldolor Is First Approved Injected Ibuprofen

For hospital patients who can't take oral drug

View FDA Statement

June 3, 2009

New Drug Fights Cancer in Dogs

Palladia approved to treat dangerous skin tumors

View FDA Statement

May 29, 2009

Besivance Approved for Bacterial Conjunctivitis

Contagious condition often called 'pink eye'

View FDA Statement

May 28, 2009

Ankle Replacement Device Approved

For people with deformed or arthritic joint

View FDA Statement

May 26, 2009

Adcirca Approved for Lung Disorder

Drug has the same active ingredient as Cialis

View FDA Statement

May 18, 2009

Risperdal Consta Approved for Bipolar Disorder

Long-acting version of antipsychotic

View FDA Statement

May 14, 2009

Cimzia Approved for Rheumatoid Arthritis

Previously sanctioned for Crohn's disease

View FDA Statement

May 7, 2009

Creon, a Pancreatic Enzyme Substitute, Approved

Derived from pig pancreas

View FDA Statement

May 7, 2009

Avastin Gets New Approval for Brain Cancer

Of the type affecting Senator Kennedy

View FDA Statement

May 7, 2009

Fanapt Sanctioned for Schizophrenia

But FDA warns against off-label use

View FDA Statement

May 6, 2009

Cycloset Approved for Type 2 Diabetes

Helps control blood sugar via the brain

View FDA Statement

April 30, 2009

Dysport, a Botox Competitor, Approved

Derived from botulinum toxin

View FDA Statement

April 24, 2009

Simponi Approved for Immune-Related Arthritis

A drug injected monthly

View FDA Statement

April 10, 2009

Benzyl Alcohol Lotion Approved for Head Lice

In people 6 months and older

View FDA Statement

April 8, 2009

Coartem Approved to Treat Malaria

U.S. travelers to stricken areas are at risk of infection

View FDA Statement

April 8, 2009

Rapid Test to Detect Bird Flu in People Approved

Results available in less than 40 minutes

View FDA Statement

March 31, 2009

Vaccine Approved for Japanese Encephalitis

Mosquito-borne virus strikes mostly in Asia

View FDA Statement

March 30, 2009

Afinitor Approved for Advanced Kidney Cancer

When cancer progresses despite other treatments

View FDA Statement

March 23, 2009

Symbyax Approved for Treatment-Resistant Depression

For people who don't respond to other antidepressants

View FDA Statement

March 20, 2009

Lexapro Approved for Adolescent Depression

For people aged 12 to 17 with major depressive disorder

View FDA Statement

March 13, 2009

First DNA Tests for HPV Approved

The virus associated with most cases of cervical cancer

View FDA Statement

March 11, 2009

Second-Generation Female Condom Approved

Protects against pregnancy and sexually transmitted disease

View FDA Statement

March 9, 2009

Device Approved for Child Heart Operations

Helps minimize scarring after surgery

View FDA Statement

February 26, 2009

Solostar Injection Pen Approved for Diabetes

Prefilled with Apidra, a rapid-acting insulin

View FDA Statement

February 19, 2009

Implanted Device Approved for Severe Obsessive-Compulsive Disorder

Reclaim device delivers electrical stimulation to the brain

View FDA Statement

February 16, 2009

Uloric Approved for Gout

The first new treatment option in 40 years

View FDA Statement

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