Hyderabad, May 22 -- : Alembic Pharmaceuticals Limited on Friday said it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP in multiple strengths ranging from 25 mcg to 300 mcg.
The approved ANDA is therapeutically equivalent to the reference listed drug, Synthroid, marketed by AbbVie, the pharma company said in a release.
Levothyroxine sodium tablets are used as replacement therapy in primary, secondary and tertiary congenital or acquired hypothyroidism.
The medication is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer, the company said....