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news.The US Food and Drug Administration (FDA) has granted final approval to Mylan subsidiary Matrix Laboratories' Zidovudine tablets, 100mg new drug application (NDA) under the President's Emergency Plan for AIDS Relief (PEPFAR).
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Zidovudine tablets are used in conjunction with other medications for controlling HIV infection and are also indicated for the prevention of mother-to-child HIV-1 transmission.
The product is included in the ARV class of drugs known as nucleoside reverse transcriptase inhibitors.
Mylan president Heather Bresch said with the approval of Zidovudine tablets we are not only able to help treat children with HIV/AIDS in developing countries, but we are also able to help prevent HIV transmission before a child is even born.
"The approval of Zidovudine tablets is a critical next step in helping to achieve UNAIDS’ goal to eliminate mother-to-child transmission by 2015," Bresch said.