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Mylan’s Matrix Receives Tentative FDA Approval Under PEPFAR For Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate Tablets

September 19, 2009

Mylan Inc. (NASDAQ: MYL) announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President’session Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

Mylan’s product represents the first-ever fixed-dose alliance of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate and now provides Matrix by numerous Tenofovir league product opportunities. This new deaden with narcotics adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used during the term of either first- or second-line treatment in adults. People use second-line therapies if and at the time that they develop resistance to initially prescribed treatments.

Mylan President Heather Bresch reported: “This product represents nevertheless any other important push in our continuing war against the global prevalent of HIV/AIDS. By combining three antiretroviral (ARV) products into a once-daily dose, we can dramatically improve the quality of care for people living with HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood that patients adhere to treatment. This innovation in addition adds some other affordable option to our large and rapidly growing portfolio of life-sustaining ARV products.”

The FDA’session trying approval under PEPFAR means that Matrix’s product meets all of the agency’s manufacturing temper, safety and efficacy standards. Although existing patents or exclusivity prevent its marketing in the U.S., the product resoluteness be eligible for purchase external part the U.S. in many developing countries.

Matrix’s wide scope of ARV products includes active pharmaceutical ingredients and first- and second-line completed doses. The visitors’s emphasis on producing affordable products has allowed it to drive into disfavor the average yearly record cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries who are receiving manipulation be pendent on Matrix ARV products.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in in greater numbers than 140 countries and territories. The company maintains one of the assiduity’session broadest and highest quality product portfolios supported by a robust product pipeline; operates the world’s third part largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.

Source: Mylan Inc

Written by Samanta · Filed Under Pharmacy Industry News