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news.Matrix Laboratories, Mylan's subsidiary, has received US Food and Drug Administration's (FDA) tentative approval for its new drug application (NDA) for Lamivudine and Zidovudine tablets, 30mg/60mg under President's Emergency Plan for AIDS Relief (PEPFAR).
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Matrix said that the FDA’s tentative approval under PEPFAR means that its product meets all of the agency’s manufacturing quality, safety and efficacy standards.
Lamivudine and Zidovudine tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are used in combination with other medications to control HIV infection.
Mylan president Heather Bresch said the approval of Lamivudine and Zidovudine is particularly important because it makes available an innovative FDC treatment option for children who are living with HIV/AIDS in developing countries.