Lupin gets US health regulator nod to market hypothyroidism tablets

Topics Lupin Pharma | USFDA

Drug firm Lupin on Friday said it has received approval from the US health regulator to market its generic Levothyroxine Sodium tablets in the American market.

The tablets are indicated for the treatment of hypothyroidism and pituitary thyrotropin suppression, Lupin said in a statement.

The company has received approval from the United States Food and Drug Administrtion (USFDA) for its supplemental abbreviated new drug application (sANDA) to market its Levothyroxine Sodium tablets in the strengths of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg, it added.

The product is a generic version of King Pharmaceuticals Research and Development LLC's Levoxyl tablets in same strengths, Lupin said.

With this approval, the company's product is now generic version of ABBVIE Inc's Synthroid tablets, Jerome Stevens Pharmaceuticals Inc's Unithroid tablets and Levoxyl tablets of King Pharmaceuticals Research and Development LLC, it added.

It is the only product approved with FDA's new narrow therapeutic index guidance for Levothyroxine, Lupin said.

The cumulatively Levothyroxine Sodium tablets USP had annual sales of around USD 2,581 million in the US, Lupin said.

Shares of Lupin Ltd closed at Rs 765.70 per scrip on the BSE, up 2.69 per cent from its previous close.



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