Matrix Laboratories, a subsidiary of Mylan Inc., USA, has received first tentative US FDA approval for generic Truvada tablets 200mg/300mg. under the President's Emergency Plan for AIDS Relief.
Robert J Coury, chairman of Matrix Labs said, "This product approval is yet another important step in providing access to a range of critical HIV medications to patients in developing countries. Mylan and Matrix continue to make a significant contribution to bringing down the cost of threes vital treatments through the expansion of our high-quality anti-retroviral franchise."
Emtricitabine and tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences Inc's Truvada tablets. Truvada is a second-line anti-HIV drug in the nucleoside reverse transcriptase inhibitor (NRTI or 'Nuke') family and is used in combination with other medications to control HIV infection. Patients often use second-line therapies if and when they develop resistance to initially prescribed treatments or experience clinical failures.
Matrix's wide range of ARV products includes active pharmaceutical ingredients (API) and first and second-line finished doses. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies.