Zydus receives USFDAs tentative approval for Levothyroxine Sodium for injection

2 Dec 2022 , 01:34 AM

Zydus Lifesciences US 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 mcgvial 200 mcgvial and 500 mcgvial 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 452 mn in the United States according to IQVIA data IQVIA MAT Sep 2022

The drug will be manufactured at the groups injectable manufacturing facility at Jarod near Vadodara India