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Zydus Cadila has announced that the US health regulator has given final approval to market generic Abacavir and Lamivudine tablets, which are primarily used for the treatment of a type of HIV infection. Zydus Cadila stated that the approval received for Abacavir and Lamivudine tablets USP are in the strength of 600 mg/300 mg.
As per the filing, the tablets are used with other antiretroviral medicines to treat human immunodeficiency virus type 1 (HIV-1) infection that causes acquired immunodeficiency syndrome (AIDS). The drugmaker also added: “The product will be manufactured at the group’s formulations manufacturing facility at special economic zone (SEZ), Ahmedabad.”
Zydus Cadila also said that it had received final approval to market generic Fondaparinux Sodium injection from the United States Food and Drug Administration (USFDA), in its regulatory filing.
Fondaparinux Sodium injection USP, which is used to treat blood clots in deep veins and the lungs received final approval in the strengths of 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL single-dose. It can also be used to prevent blood clots in patients undergoing certain types of surgeries.
As per the company’s statement, the injections will be manufactured at a partner’s manufacturing site. Also, the group has now more than 230 approvals and 330 abbreviated new drug applications (ANDAs).
