New Delhi: Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP in multiple strengths.
According to the company’s regulatory filing, the approval covers Levothyroxine Sodium Tablets USP in 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.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Synthroid Tablets, marketed by AbbVie Inc.
Levothyroxine sodium tablets are indicated as replacement therapy in primary, secondary and tertiary congenital or acquired hypothyroidism. The medication is also used as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
The company stated that the product has an estimated market size of USD 1,869 million for the twelve months ending March 2026, according to IQVIA data.
Alembic Pharmaceuticals further informed that it has now received a cumulative total of 239 ANDA approvals from the USFDA, comprising 220 final approvals and 19 tentative approvals.
The company highlighted that it is a vertically integrated research and development pharmaceutical company established in 1907 and manufactures and markets generic pharmaceutical products globally. Alembic’s research and manufacturing facilities are approved by several international regulatory authorities, including the USFDA.
According to the company, Alembic is also among the leading branded generic pharmaceutical companies in India, with its products marketed through a field force of over 5,500 professionals.
