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.
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According to IQVIA data, Levothyroxine Sodium injection had annual sales of USD 45.2 million in the US market.
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