Lupin gets sANDA approval for Levothyroxine tablets

Pharma major, Lupin, announced that it has received sANDA approval for Levothyroxine tables, on Friday.

In a press release, the company said that supplemental Abbreviated New Drug Application (sANDA) was received for Levothyroxine Sodium tablets for powers ranging 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, from the United States Food and Drug Administration (USFDA). The estimated user market is a generic equivalent of UNITHROID 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.

The statement released by the company also stated that, Levothyroxine Sodium Tablets of all USP ranges was originally approved on January, 2019.

After the latest sANDA approval, its Levothyroxine Sodium Tablets is now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID and UNITHROID. Levothyroxine Sodium tablets had annual revenue appetite of nearly $2581 million in the US. The Levothyroxine Sodium tablets are indicated for Hypothyroidism and Pituitary Thyrotropin Suppression.

On Friday, shares of Lupin closed at Rs. 756 per share, higher by 2 per cent on BSE. The stock had opened at Rs. 742.00 compared to its previous close of Rs. 741.35.