FDA APPROVES GENERIC HIV DRUG FOR PEPFAR USE

The FDA has approved Aurobindo Pharma's generic didanosine pediatric oral solution, 10 mg/mL, allowing the drug to be marketed in the U.S. and used in the President's Emergency Plan for AIDS Relief (PEPFAR).

PEPFAR, launched in 2003, aims to care for and treat people affected by HIV/AIDS. The program focuses on 15 focus countries, the majority of which are in Africa. Nearly 30 million people in Africa have HIV, according to a recent Department of State announcement.

Aurobindo's drug is equivalent to Videx Pediatric Powder manufactured by Bristol-Myers Squibb. The drug is approved for use in combination with other antiretroviral drugs for treating HIV.

Because drugs that do not conform to standards of potency, purity, stability or good manufacturing procedures may pose a threat by increasing chance of substandard performance, treatment failure and emergence of resistant viral strains, PEPFAR funds only the HIV drugs that have undergone stringent regulatory review, according to the FDA.