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news.Mylan Laboratories, a subsidiary of Mylan, has received tentative approval from FDA for its new drug application (NDA) for Abacavir Sulfate and Lamivudine tablets, 60mg/30mg.
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This fixed-dose combination product was developed for use in treating children with HIV/AIDS and is based on the adult-strength, brand version of the product EPZICOM, by Viiv Healthcare.
Abacavir Sulfate and Lamivudine Tablets are used in combination with other medications to control HIV infection.
Mylan CEO Heather Bresch said the approval of Abacavir Sulfate and Lamivudine further supports Mylan’s mission to continue expanding access to high quality medicine around the world.