AUROBINDO WINS APPROVAL FOR GENERIC PEDIATRIC TREATMENT FOR HIV

The FDA has approved Aurobindo Pharma's generic pediatric HIV drug, didanosine oral solution, 10 mg/mL. The final approval allows the drug to be marketed in the U.S. and purchased for use 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. 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 HIV strains, PEPFAR funds only the HIV drugs that have undergone stringent regulatory review, according to the FDA.

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.