Lupin gets USFDA approval to market hypothyroidism treatment drug

Drug firm Lupin Monday said it has received approval from the US health regulator to market Levothyroxine Sodium tablets used for treatment of hypothyroidism.

The company has received an approval from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 25 microgram (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.

The product is a generic version of AbbVie Inc's Synthroid tablets in the same strengths, it added.

According to IQVIA MAT September 2018 data, Levothyroxine Sodium tablets had an annual sale of about $ 2.5 billion in the US market, Lupin said.
 

The tablets are indicated for hypothyroidism and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer, it added.

Shares of Lupin closed at Rs 865.50 per scrip on the BSE, up 0.69 per cent from the previous close.