LUPIN gets USFDA nod to market medicine to cure Thyroid

BALTIMORE | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press-release submitted to the Indian Stock Exchanges by Lupin Ltd, the company said of having got approval from USFDA (US Food & Drugs Administration) to market medicine to cure thyroid and thyroid related diseases.

The company release as submitted to the Indian Bourses read that, “Lupin receives sANDA approval from US FDA for Levothyroxine Sodium Tablets USP AB rating to Reference Listed Drug, LEVOXYL®” further read that, Pharma major Lupin Limited (Lupin) announced that it has received approval for its sANDA (Supplement Abbreviated New Drug Application) for Levothyroxine Sodium Tablets USP from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of LEVOXYL® 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 King Pharmaceuticals Research and Development LLC.

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® manufactured by ABBVIE Inc.

Earlier, Lupin also received sANDA approval dated September 19, 2019 for its 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® manufactured by Jerome Stevens Pharmaceuticals 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®, UNITHROID® and LEVOXYL® and are the only product approved with FDA’s new Narrow Therapeutic Index guidance for Levothyroxine.

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

Cumulatively, Levothyroxine Sodium Tablets USP (RLDs: SYNTHROID®, UNITHROID® and LEVOXYL®) had annual sales of approximately USD 2,581 million in the US (IQVIA MAT June 2019).


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