FDA approves third indication for Lupin’s generic Levoxyl
Lupin has received the Food and Drug Administration’s nod for a new indication for levothyroxine sodium tablets.
The product now is approved as a generic of King Pharmaceutical’s Levoxyl 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 product was originally approved on Jan. 18 as the generic of AbbVie’s Synthroid.
Lupin received the FDA’s green light on Sept. 19 for the product as a generic of Jerome Stevens’ Unithroid,
Lupin's product is indicated for: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism; as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Cumulatively, levothyroxine sodium tablets had a market value of roughly $2.5 billion, according to IQVIA June 2019 data.