Zydus Lifesciences gets FDA tentative approval for Levothyroxine Sodium generic

Zydus Lifesciences (previously Cadila Healthcare), through its US subsidiary Zydus Pharmaceuticals (USA), has secured tentative approval for Levothyroxine Sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial from the US Food and Drug Administration (FDA).

The approved product is a generic version of Levothyroxine Sodium injection manufactured by Fresenius Kabi USA.

Levothyroxine Sodium injection has FDA approval for the treatment of myxedema coma.

As per IQVIA data, Levothyroxine Sodium injection had annual sales of $45.2 million in the US.

Zydus Lifesciences gets FDA tentative approval for Levothyroxine Sodium generic. Photo courtesy of Zydus Cadila.

Zydus Lifesciences plans to manufacture its generic at its injectable manufacturing facility at Jarod, near Vadodara.

From the beginning of the filing process in FY 2003-04, the Indian pharma company has 334 approvals and has to date filed more than 431 abbreviated new drug applications (ANDAs).