USFDA22 May 2026, 11:00 am
Alembic Pharma Gets USFDA Final Nod for Levothyroxine
AI Summary
Alembic Pharmaceuticals Ltd. has received USFDA final approval for Levothyroxine Sodium Tablets USP in multiple strengths (25 mcg to 300 mcg). The approved ANDA is therapeutically equivalent to AbbVie's Synthroid Tablets. These tablets are used as replacement therapy for hypothyroidism and as an adjunct to surgery and radioiodine therapy for thyroid cancer. The market size for Levothyroxine Sodium Tablets USP is estimated at US$ 1,869 million for the twelve months ending March 2026, according to IQVIA. Alembic now has a total of 239 ANDA approvals from the USFDA.
Key Highlights
- Alembic Pharma receives USFDA final approval for Levothyroxine Sodium Tablets USP.
- The drug is indicated for hypothyroidism and thyroid cancer management.
- The approved ANDA is therapeutically equivalent to Synthroid Tablets of AbbVie.
- Levothyroxine Sodium Tablets USP market size is US$ 1,869 million (IQVIA).
- Alembic now has 239 total ANDA approvals from USFDA.