FDA tentatively approves Matrix Labs' HIV treatment

PITTSBURGH The Food and Drug Administration has given tentative approval to a subsidiary of Mylan under the President’s Emergency Plan for AIDS Relief for a drug to treat HIV in children, Mylan announced Tuesday.

The FDA gave the tentative approval for Matrix Labs’ new drug application for efavirenz tablets in the 50-mg, 100-mg and 200-mg strengths. The drug is a non-nucleoside reverse transcriptase inhibitor used to treat HIV infections in patients whether they have received prior treatment or not.

“This new drug application represents another successful innovation by Matrix in the fight against HIV/AIDS,” Mylan president Heather Bresch said in a statement. Our HIV/AIDS antiretroviral franchise continues to grow and to bring more affordable, high-quality medications to patients in the developing world.”

The tentative approval under PEPFAR means that the drug meets FDA requirements for approval. While existing patents and exclusivity prevent Matrix from marketing it in the United States, it will be available in many developing countries. Bristol-Myers Squibb Co. markets efavirenz in the United States under the brand name Sustiva.