Lupin gets FDA nod for generic Unithroid

Lupin has received the Food and Drug Administration’s green light on its supplemental abbreviated new drug application for its generic of Jerome Stevens' Unithroid (levothyroxine sodium tablets). The company's generic had previously been approved as a generic of AbbVie's Synthroid in January.

Lipin's generic is available in dosage strengths of 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.

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) suppression: as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Levothyroxine sodium tablets had a market value of approximately $2.6 billion, according to IQVIA June 2019 data.