Generic pediatric AIDS Drug gets U.S. OK

June 28, 2006

The U.S. Food and Drug Administration has tentatively approved the generic version of Abacavir Sulfate Oral Solution for use by pediatric AIDS victims.

The pharmaceutical manufactured by Aurobindo Pharma LTD. of India, is the first generic version of the already approved Ziagen Oral Solution brand of abacavir manufactured by GlaxoSmithKline.

The 20mg pediatric formulation is indicated for use in pediatric patients from 3 months through 13 years of age who are HIV infected.

The agency's tentative approval of Aurobindo's abacavir solution means that although existing patents and exclusivity prevent marketing of the product within the United States, it meets all FDA quality, safety and efficacy standards for U.S. marketing.

The tentative approval will allow the generic drug to become available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief, the FDA said.

"Saving the lives of children with HIV is a foremost goal of PEPFAR," said Gary Buehler, the director of the FDA's Office of Generic Drugs. "The agency's action ... can help bring effective treatment to thousands of infected children, and thereby dramatically brighten their future."

Copyright 2006 by United Press International

Explore further: Study begins in Kenya for recently-approved pediatric HIV treatment

Related Stories

Study begins in Kenya for recently-approved pediatric HIV treatment

December 1, 2015
The Drugs for Neglected Diseases initiative (DNDi) has begun an implementation study of a recently-approved paediatric antiretroviral (ARV) treatment in order to address the urgent need for better medicines for children living ...

Child-friendly formulation of WHO-recommended HIV treatment approved by FDA

June 4, 2015
The Paediatric HIV Treatment Initiative welcomes this important step towards closing the treatment gap for children with HIV

Recommended for you

How a poorly explored immune cell may impact cancer immunity and immunotherapy

November 17, 2017
The immune cells that are trained to fight off the body's invaders can become defective. It's what allows cancer to develop. So most research has targeted these co-called effector T-cells.

Hibernating ground squirrels provide clues to new stroke treatments

November 17, 2017
In the fight against brain damage caused by stroke, researchers have turned to an unlikely source of inspiration: hibernating ground squirrels.

A walk at the mall or the park? New study shows, for moms and daughters, a walk in the park is best

November 17, 2017
Spending time together with family may help strengthen the family bond, but new research from the University of Illinois shows that specifically spending time outside in nature—even just a 20-minute walk—together can ...

Decrease in sunshine, increase in Rickets

November 17, 2017
A University of Toronto student and professor have teamed up to discover that Britain's increasing cloudiness during the summer could be an important reason for the mysterious increase in Rickets among British children over ...

Brain activity buffers against worsening anxiety

November 17, 2017
Boosting activity in brain areas related to thinking and problem-solving may also buffer against worsening anxiety, suggests a new study by Duke University researchers.

Investigating patterns of degeneration in Alzheimer's disease

November 17, 2017
Alzheimer's disease (AD) is known to cause memory loss and cognitive decline, but other functions of the brain can remain intact. The reasons cells in some brain regions degenerate while others are protected is largely unknown. ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.