FDAnews Drug Daily Bulletin

The FDA has granted tentative approval for Matrix Laboratories’ generic version of Boehringer Ingelheim’s 200-mg Viramune tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI) for use in combination with other antiretrovirals for the treatment of HIV. 

The generic Viramune (nevirapine) application was considered under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion program aimed at combating HIV and other disease in 114 countries — including 15 focus countries primarily in Africa — that President Bush announced in 2003. 

Tentative approval means the FDA has concluded that a drug product has met all required standards but is not eligible for marketing in the U.S. because of existing patents or exclusivity rights. The product is eligible for consideration for purchase outside the U.S. under the PEPFAR program, the agency said.

India-based Matrix received FDA approval for its generic version of GlaxoSmithKline’s 300-mg Retrovir (zidovudine) tablets, another NNRTI used in combination with other antiviral drugs to treat HIV, in February.

Because GSK’s patents on Retrovir have expired, Matrix’s generic product can be sold in the U.S. as well as be purchased under PEPFAR.