Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories'New Drug Application (NDA) for Efavirenz Tablets
Tue, 12/22/2009 - 3:34am
Mylan Inc. has announced that its subsidiary Matrix Laboratories Limited has receivedtentative approval from the FDA under thePresident's Emergency Plan for AIDS Relief (PEPFAR) for its New DrugApplication (NDA) for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. Theseinnovative pediatric dosages in tablet form were developed by Matrix for usein treating pediatric HIV/AIDS. Mylan President Heather Bresch commented: "This New Drug Applicationrepresents another successful innovation by Matrix in the fight againstHIV/AIDS. Our HIV/AIDS antiretroviral (ARV) franchise continues to grow and tobring more affordable, high quality medications to patients in the developingworld. We are extremely pleased to be able to add these new dosages to thebasket of treatment options currently available to the medical community, andto expand our portfolio of products for treating pediatric HIV/AIDS."Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) thathas been found to be effective in many combination regimens for the treatmentof HIV infection, both in treatment-naive and in treatment-experiencedindividuals. The FDA's tentative approval under PEPFAR means that Matrix's productmeets all of the agency's manufacturing quality, safety and efficacystandards. Although existing patents or exclusivity prevent its marketing inthe U.S., the product will be eligible for purchase outside the U.S. in manydeveloping countries.