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. Levothyroxine Sodium injection had annual sales of USD 45.2 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022).
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
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