FDA OKs 50th & 51st anti-retroviral drugs

August 14, 2007

The U.S. Food and Drug Administration has tentatively approved nevirapine tablets and a pediatric medication used to treat the human immunodeficiency virus.

The FDA said the pediatric triple-fixed dose combination tablet of lamivudine, stavudine and nevirapine is the first fixed dose anti-HIV product designed to treat children under the age of 12 years.

The two drugs mark the 50th and 51st AIDS-related drugs approved or tentatively approved for purchase under the President's Emergency Plan for AIDS Relief.

The fixed dose combination comprises a complete HIV regimen taken twice daily and can also be dissolved in water for children who cannot swallow tablets. The FDA said the fact all three drugs are combined into one tablet that can be stored, distributed and administered easily is a significant advance in the treatment of children infected with HIV.

The FDA said its tentative approval means although existing patents or other factors prevent the sale of the products in the United States, the medications meets all U.S. manufacturing quality and clinical safety and efficacy requirements, helping ensure AIDS patients abroad can receive the same quality of medications as Americans.

Copyright 2007 by United Press International

Explore further: Researchers use silk to cultivate organ tissues in the lab

Related Stories

Researchers use silk to cultivate organ tissues in the lab

April 2, 2015

Few organs in the body are as complicated as the human brain, a tight spiderweb of neurons that shoots electrical signals across synapses to control all our thoughts and movements. When something goes wrong—as it does when ...

Food poisoning: New detection method for bacterial toxin

April 1, 2015

The Bacillus cereus bacteria is one of the potential causes of food poisoning. Indeed, a recent study in Analytical and Bioanalytical Chemistry shows that this versatile pathogen produces 19 different variants of a poison ...

Bone marrow-on-a-chip unveiled

May 5, 2014

The latest organ-on-a-chip from Harvard's Wyss Institute for Biologically Inspired Engineering reproduces the structure, functions and cellular make-up of bone marrow, a complex tissue that until now could only be studied ...

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...

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.