Pharma predominant Lupin Limited (Lupin) has received approval for its sANDA for Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, one hundred twenty five mcg, 137 mcg, 150 mcg, one hundred seventy five mcg, two hundred mcg, and three hundred mcg, from the US Food and Drug Administration (U.S. FDA), to marketplace a time-honored equivalent of UNITHROID® 25 mcg, 50 mcg, seventy five mcg, 88 mcg, one hundred mcg, 112 mcg, one hundred twenty five mcg, 137 mcg, one hundred fifty mcg, 175 mcg, two hundred mcg, and three hundred mcg, manufactured via Jerome Stevens Pharmaceuticals Inc.

Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, a hundred mcg, 112 mcg, 125 mcg, 137 mcg, one hundred fifty mcg, a hundred seventy five mcg, two hundred mcg, and 300 mcg was at the beginning accredited on January 18, 2019 as common equivalent of SYNTHROID® 25 mcg, 50 mcg, seventy five mcg, 88 mcg, one hundred mcg, 112 mcg, one hundred twenty five mcg, 137 mcg, 150O mcg, a hundred seventy five mcg, 200 mcg, and 300 mcg, manufactured through ABBVIE Inc.

With this sANDA approval, Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, seventy five mcg, 88 mcg, 100 mcg, 112 mcg, a hundred twenty five mcg, 137 mcg, 150 mcg, a hundred seventy five mcg, two hundred mcg, and three hundred mcg are actually AB rated (therapeutically equal) with Reference Listed Drugs, SYNTHROID® and UNITHROID®.

Lupin’s Levothyroxine Sodium Tablets are indicated for:

– Hypothyroidism: As alternative remedy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or obtained hypothyroidism

– Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an accessory to surgical procedure and radioiodine remedy in the control of thyrotropin-based nicely-differentiated thyroid cancer Levothyroxine Sodium Tablets USP (RLD: UNITHROID® and SYNTHROID®) had annual sales of about USD 2S81 million inside the US (IQVIA MAT June 2019).