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 .​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 . ​Latest News [ SOBAN NEWS: International and National ]
