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: New US restrictions on painkiller to take effect

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

Using computers to design drugs

6 hours ago

Designing a new medicine is an expensive and time consuming business. Typically it takes around $2 billion and ten years for a new drug to move from its initial design in the lab, to the clinic. All the ...

Lilly psoriasis drug fares well in late-stage test

11 hours ago

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease.

New US restrictions on painkiller to take effect

Aug 21, 2014

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

User comments : 0