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news.The US Food and Drug Administration (FDA) has granted tentative approval for Matrix Laboratories' new drug application (NDA) of Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300mg/300mg, co-packaged with Nevirapine Tablets, 200mg.
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Matrix’s Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300mg/300mg are generic equivalent to
Epivir of GlaxoSmithKline, Viread of Gilead Sciences and Viramune of Boehringer Ingelheim.
According to the Mylan’s subsidiary Matrix, this co-pack of ARV products is indicated for pregnant women suffering from HIV/AIDS in certain countries where Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are approved for use during pregnancy.
Mylan president Heather Bresch said the approval of Lamivudine / Tenofovir Disoproxil Fumarate Tablets co-packaged with Nevirapine Tablets is an important product developed by Matrix for the treatment of HIV/AIDS.