FDA Tentatively Approves Pediatric Formulations to Treat HIV Infection

The FDA granted a tentative approval for 2 dosages of abacavir/lamivudine tablets for oral suspension to treat HIV-1 infection in pediatric patients, according to a Mylan, Inc, press release.

The tentative approval, arriving just a few days after World AIDS Day, was possible through the president’s Emergency Plan for AIDS Relief program, and means that the formulations meet the FDA’s quality, safety, and efficacy standards, according to Mylan.

The flavored tablets are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents for pediatric patients, Mylan stated.

Some of the adverse reactions to the 2 drugs among adult patients with HIV-1 were drug hypersensitivity, insomnia, depression, and vertigo. Among pediatric patients with HIV-1 in clinical trials, the most common adverse reactions included nausea, skin rashes, fever, and ear/nose throat infections.

In 2012, Mylan entered into an agreement with Clinton Health Access Initiative (CHAI) and ViiV Healthcare to work together to push for regulatory authority submission, production, and distribution of the new formulation at a low cost to resource-limited countries, according to Mylan.

"This new flavored, pediatric formulation is designed to help parents and caregivers give accurate doses of the medication depending on the weight of the child,” Mylan CEO

Heather Bresch

said in a press release. “The innovative work being done at Mylan, in combination with our partnership with ViiV and CHAI, has enabled us to develop this new product to treat children with HIV, a particularly vulnerable population."