Wednesday , December 1 2021

Zydus Cadila receives USFDA’s approval for Abacavir & Lamivudine Tablets, Fondaparinux Sodium Injection

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Abacavir and Lamivudine Tablets USP, 600 mg/300 mg (US RLD- EPZICOM), and Fondaparinux Sodium Injection USP, 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 (US RLD- ARIXTRA).

Abacavir and Lamivudine Tablets are used with other antiretroviral medicines to treat Human Immunodeficiency Virus-type 1 (HIV-1) infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad in the state of Gujarat.

Fondaparinux Injection is used to treat blood clots in deep veins (deep vein thrombosis) and the lungs (pulmonary embolism). It can also be used to prevent blood clots in patients undergoing certain types of surgeries. It will be manufactured at a partner’s manufacturing site.

The group has more than 230 approvals and has so far filed over 330 ANDAs since the commencement ofthe filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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