Under PEPFAR, Matrix granted tentative approval for novel co-packaged HIV/AIDS treatment

PITTSBURGH — Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

Matrix said that lamivudine/tenofovir disoproxil fumarate tablets in the 300-mg/300-mg strength, co-packaged with nevirapine tablets in the 200-mg strength, would be eligible for purchase outside of the United States in certain developing countries. Lamivudine, tenofovir disoproxil fumarate and nevirapine are the generic versions of GlaxoSmithKline's Epivir, Gilead Sciences' Viread and Boehringer Ingelheim's Viramune, respectively.

"The approval of lamivudine/tenofovir disoproxil fumarate tablets co-packaged with bevirapine tablets is an important product developed by Matrix for the treatment of HIV/AIDS," Mylan president Heather Bresch said. "For the first time, it makes available a co-pack option that can help patients with the carrying and storage of this critical first-line ARV cocktail. Co-packs are convenient and may help to facilitate patient compliance with what often can be part of a burdensome drug regimen for HIV/AIDS patients managing many prescriptions and therapies."