Mylan has reported that its subsidiary, Matrix Laboratories (Matrix) has received tentative approval from the FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR), for its New Drug Application (NDA) for Efavirenz tablets, 50mg, 100mg and 200mg.
These pediatric dosages in tablet form were developed by Matrix for use in treating pediatric HIV/AIDS.
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) that has been found to be effective in many combination regimens for the treatment of HIV infection, both in treatment-naive and in treatment-experienced individuals.
The FDA’s tentative approval under PEPFAR means that Matrix’s product meets all of the agency’s manufacturing quality, safety and efficacy standards. Although, existing patents or exclusivity prevent its marketing in the US, and the product will be eligible for purchase outside the US in many developing countries, said the company.
Heather Bresch, president of Mylan, said: “This New Drug Application represents another successful innovation by Matrix in the fight against HIV/AIDS. Our HIV/AIDS antiretroviral (ARV) franchise continues to grow and to bring more affordable, high quality medications to patients in the developing world.
“We are extremely pleased to be able to add these new dosages to the basket of treatment options currently available to the medical community, and to expand our portfolio of products for treating pediatric HIV/AIDS.”