Zydus Lifesciences’ arm receives USFDA’s approval for Levothyroxine Sodium for Injection

28 Nov 2022 Evaluate

Zydus Lifesciences’ U.S. subsidiary -- Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levothyroxine Sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial (USRLD: Levothyroxine Sodium injection manufactured by Fresenius Kabi USA, LLC).

Levothyroxine Sodium injection is indicated for the treatment of myxedema coma. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India. Levothyroxine Sodium injection had annual sales of $45.2 million in the United States according to IQVIA data (IQVIA MAT Sep 2022). The group now has 334 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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