Drug Approvals Information from the FDA

November 6, 2009

Istodax Approved for Cutaneous T-Cell Lymphoma

It's a disfiguring cancer affecting the skin

WEDNESDAY, Nov. 12 (HealthDay News) -- The U.S. Food and Drug Administration has approved a 30-minute onset of action for Focalin XR (dexmethylphenidate HCI extended release) to treat attention-deficit hyperactivity disorder (ADHD), maker Novartis Pharmaceuticals said Wednesday.

The early onset could especially benefit children ages 6 to 12 during the morning as they get ready for school, the company said in a news release. The drug helps curtail symptoms for up to 12 hours.

ADHD affects about 3 percent to 6 percent of children in the United States, with symptoms including inattention, hyperactivity, and impulsive behavior, Novartis said.

The new labeling is based on clinical data, including a study of 86 children ages 6 to 12. The drug provided significant symptom improvement 30 minutes after administration, compared to a non-medicinal placebo, the company said.

The most common adverse reactions included abdominal pain, headache, increased appetite, and viral gastroenteritis.

More information

The FDA has more about this drug.

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

February 9, 2009

1st Drug From Genetically Altered Animals Approved

ATryn sanctioned for rare genetic blood disorder

View FDA Statement

February 6, 2009

First Ablation Catheters Approved for Atrial Fibrillation

Designed to treat irregular heartbeat when medication doesn't work

View FDA Statement

February 4, 2009

Vectical Ointment Approved for Psoriasis

Vitamin D3 is active ingredient

View FDA Statement

February 2, 2009

Kapidex Approved for Acid Reflux

A reformulated version of Prevacid

View FDA Statement

January 28, 2009

Gelnique Approved for Overactive Bladder

A topical gel for treating symptoms

View FDA Statement

January 16, 2009

Riastap Approved for Rare Blood Disorder

Congenital fibrinogen deficiency can cause uncontrolled bleeding

View FDA Statement

January 15, 2009

Savella Approved for Fibromyalgia

Expected in pharmacies by March

View FDA Statement

January 13, 2009

Diagnostic Approved to Detect C. diff

An infection commonly acquired in hospitals

View FDA Statement

December 31, 2008

Nucleic Acid Test Screens for HIV

In donated blood and tissue

View FDA Statement

December 29, 2008

Degarelix Approved for Advanced Prostate Cancer

Suppresses testosterone production

View FDA Statement

December 22, 2008

Zolpimist Approved for Insomnia

Oral spray contains Ambien's active ingredient

View FDA Statement

December 22, 2008

Gleevec Approved for Use After Cancer Surgery

Drug first sanctioned in 2001

View FDA Statement

December 19, 2008

Mozobil Boosts Stem Cells Before Bone Marrow Transplants

Could help people with certain forms of blood cancer

View FDA Statement

December 16, 2008

TriLipix Approved to Help Lower Cholesterol

To be used alone, or in combination with a statin

View FDA Statement

November 24, 2008

Promacta Approved for Rare Blood Disorder

Affects about 60,000 people in United States

View FDA Statement

November 21, 2008

Banzel Approved for Lennox-Gastaut Syndrome

A severe form of epilepsy

View FDA Statement

November 12, 2008

Early Onset Approved for ADHD Drug

30-minute onset of action for Focalin XR

View FDA Statement

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