Alembic Pharma gets USFDA nod for generic levothyroxine sodium tablets

The approval by USFDA is for the Abbreviated New Drug Application of levothyroxine sodium tablets of various strengths

Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of levothyroxine sodium tablet indicated as a replacement therapy for hypothyroidism.

The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of levothyroxine sodium tablets of strengths 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, Alembic said in a regulatory filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Synthroid tablets, 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, of AbbVie, Inc, it added.

 

Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism, the company said.

Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Levothyroxine sodium tablets have an estimated market size of $1,869 million for 12 months ended March 2026, Alembic said citing IQVIA data.