FDA OKs 50th & 51st anti-retroviral drugs

Aug 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: US aims to cut antibiotic use

add to favorites email to friend print save as pdf

Related Stories

Bone marrow-on-a-chip unveiled

May 05, 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 ...

Recommended for you

US aims to cut antibiotic use

Mar 27, 2015

US President Barack Obama on Friday rolled out plans to cut inappropriate antibiotic use by half, in an effort to tackle drug resistance.

Questions over value of new antibiotics to tackle resistance

Mar 26, 2015

In the first installment of a new series, Peter Doshi, Assistant Professor at the University of Maryland School of Pharmacy and Associate Editor at The BMJ, asks why authorities are approving drugs with little evidence they d ...

User comments : 0

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.