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Zydus Cadila has received final approval from the US health regulator to market generic Abacavir and Lamivudine tablets used in the treatment of a type of HIV infection.
According to a regulatory filing, the company has also received final approval from the United States Food and Drug Administration (USFDA) to market generic Fondaparinux Sodium injection. The USFDA approval is for Abacavir and Lamivudine tablets USP in the strength of 600 mg/300 mg.
The tablets are used with other antiretroviral medicines to treat human immunodeficiency virus-type 1 (HIV-1) infection that causes acquired immune deficiency syndrome (AIDS). “The product will be manufactured at the group’s formulations manufacturing facility at special economic zone (SEZ), Ahmedabad,” Zydus Cadila said.
Approval for Fondaparinux Sodium injection USP is 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. Fondaparinux injection is used to treat blood clots in deep veins and lungs. It can also be used to prevent blood clots in patients undergoing certain types of surgeries, the filing said.
“It will be manufactured at a partner’s manufacturing site,” it added.
The group now has more than 230 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process. Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 357.80 per scrip on BSE, down 0.54 per cent from their previous close.
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