Zydus Lifesciences gets tentative USFDA approval for Levothyroxine Sodium

28 Nov 2022 , 09:16 AM

The United States Food and Drug Administration (USFDA) has tentatively approved Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. to market Levothyroxine Sodium injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial.

The levothyroxine sodium injection is used to treat myxedema coma. The drug will be manufactured at the group’s injectable manufacturing facility in Jarod, India, near Vadodara.

According to IQVIA data for the month of September 2022, the annual sales of levothyroxine sodium injection in the United States were USD 45.2 million.

Since the beginning of the filing process in FY 2003-04, the group has received 334 approvals and filed over 431 ANDAs.

At around 9.17 AM, Zydus Lifesciences was trading at Rs403.30 up by Rs1.5 or 0.37% from its previous closing of Rs401.80 on the BSE.

For feedback and suggestions, write to us at [e-mail]