Zydus Lifesciences has received approval from the United States Food and Drug Administration (USFDA) to market Levothyroxine Sodium injection, used to treat thyroid hormone deficiency. The company's US-based unit has received tentative approval from the US Food and Drug Administration (USFDA) to market the medication, the drug firm said in a regulatory filing.
“Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) 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," Zydus Lifesciences said in a regulatory filing.
Levothyroxine Sodium injection is indicated for the treatment of myxedema coma.
The drug will be manufactured at the company's injectable manufacturing facility at Jarod, near Vadodara.
According to IQVIA data, Levothyroxine Sodium injection had annual sales of USD 45.2 million in the US market.
