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25 Sep 2019
Admin
News Article

Lupin receives sANDA approval from USFDA for Levothyroxine Sodium Tablets

Pharma major Lupin Limited announced that it has received approval for its sANDA for Levothyroxine Sodium Tablets USP, 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 (U.S. FDA), to market 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, manufactured by Jerome Stevens Pharmaceuticals Inc. Lupin's Levothyroxine Sodium Tablets USP, 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 was originally approved on January 18, 2019 as generic equivalent of SYNTHROID 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150O mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by ABBVIE Inc. With this sANDA approval, Lupin's Levothyroxine Sodium Tablets USP, 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 are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID and UNITHROID. Lupin's Levothyroxine Sodium tablets are indicated for hypothyroidism as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism, Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.'

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