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Lupin gets USFDA nod for its Levothyroxine Sodium tablets

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Press Trust of India New Delhi
Last Updated : Sep 20 2019 | 4:35 PM IST

Pharma major Lupin on Friday said it has received approval from the US health regulator for its generic Levothyroxine Sodium tablets used for treatment of hypothyroidism and pituitary thyrotropin suppression.

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Levothyroxine Sodium tablets USP 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, Lupin said in a statement.

The product is a generic version of Jerome Stevens Pharmaceuticals Inc's Unithroid tablets in the same strengths, it added.

According to IQVIA MAT June 2019 data, Levothyroxine Sodium tablets USP had total annual sales of about USD 2,581 million in the US, Lupin said.

The tablets are indicated for hypothyroidism and pituitary thyrotropin suppression, it added.

Shares of Lupin Ltd closed at Rs 756 per scrip on the BSE, up 1.98 per cent from its previous close.

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First Published: Sep 20 2019 | 4:35 PM IST

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