FDA approves Lupin’s generic Synthroid tablets
Lupin has received Food and Drug Administration approval for its generic Synthroid.
Lupin’s generic Synthroid will be available in dosage strengths of 5 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg.
The company’s generic of AbbVie’s branded product is indicated as replacement therapy for patients with thyroidal, pituitary and hypothalamic congenital or acquired hypothyroidism. It also is indicated as an adjunct to surgery and radioiodine therapy in patients managing thyroptropin dependent, well-differntiated thyroid cancer.
The drug had a market size of roughly $2.5 billion for the 12 months ended September 2018, according to IQVIA data.
Lupin’s generic Synthroid will be available in dosage strengths of 5 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg.
The company’s generic of AbbVie’s branded product is indicated as replacement therapy for patients with thyroidal, pituitary and hypothalamic congenital or acquired hypothyroidism. It also is indicated as an adjunct to surgery and radioiodine therapy in patients managing thyroptropin dependent, well-differntiated thyroid cancer.
The drug had a market size of roughly $2.5 billion for the 12 months ended September 2018, according to IQVIA data.