Mylan's Matrix gets tentative FDA approval for novel "co-packaged" version of HIV/AIDS drug

US generic drugmaker Mylan (Nasdaq: MYL) says that its Indian subsidiary Matrix Laboratories has received tentative approval for its combination HIV/AIDS treatment from the US Food and Drug Administration through the President's Emergency Plan for AIDS Relief (PEPFAR). The New Drug Application is for lamivudine/tenofovir disoproxil fumarate tablets, 30 mg/300mg, co-packaged with nevirapine, 200mg. The product will be eligible for purchase outside the USA in certain developing countries.

Mylan president Heather Bresch said the approval “is an important product developed by Matrix for the treatment of HIV/AIDS. 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."

This product offering is the first generic ARV drug product in a co-pack form and can be used alone or in combination with other ARVs for the treatment of HIV/AIDS. The FDA's tentative approval through PEPFAR signifies that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.