The United States Food and Drug Administration (USFDA) has tentatively approved Zydus Lifesciences' (formerly known as Cadila Healthcare) US subsidiary Zydus Pharmaceuticals (USA) to market Levothyroxine Sodium injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial.
The levothyroxine sodium injection is used to treat myxedema coma. The drug will be manufactured at the group's injectable manufacturing facility in Jarod, near Vadodara.
Since the beginning of the filing process in FY 2003-04, the group has received 334 approvals and filed over 431 ANDAs.
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