Zydus Lifesciences on Monday said it has received approval from the US health regulator 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 to market the medication, the drug firm 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.
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