The FDA has granted tentative approval of Aurobindo Pharma's generic abacavir sulfate tablets for the treatment of AIDS.
In the May 18 announcement, the FDA said the approval had been made in association with the President's Emergency Plan for AIDS Relief (PEPFAR), which provides $15 billion over five years to fight the spread of AIDS and assist those infected with or affected by it. Abacavir, the first generic version of GlaxoSmithKline's Ziagen, will now be considered for purchase under PEPFAR.
The drug is in the non-nucleoside reverse transcriptase inhibitors class and helps keep the AIDS virus from reproducing. Existing patents or exclusivities prevent it from being sold in the U.S., but it can be marketed and used in other countries under PEPFAR.
