Alembic Pharmaceuticals Ltd on Friday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP across multiple strengths.
The approved product includes 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.
According to the company, the approved ANDA is therapeutically equivalent to AbbVie’s reference listed drug (RLD), Synthroid Tablets.
Levothyroxine sodium tablets are indicated as replacement therapy in primary, secondary and tertiary hypothyroidism, and are also used as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Alembic Pharmaceuticals said the product has an estimated market size of US$1.869 billion for the twelve months ended March 2026, according to IQVIA data.
With this approval, Alembic now has a cumulative total of 239 ANDA approvals from the USFDA, including 220 final approvals and 19 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated pharmaceutical company engaged in manufacturing and marketing generic pharmaceutical products globally.
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