Alembic Pharmaceuticals gets USFDA approval for Triamcinolone Acetonide Injectable Suspension

Alembic Pharmaceuticals Limited today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, in both single-dose and multiple-dose vials. This approval includes 200 mg/5 mL and 400 mg/10 mL (40 mg/mL) presentations, therapeutically equivalent to Kenalog-40 Injectable Suspension.

The approved product is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. This approval contributes to Alembic's cumulative total of 227 ANDA approvals, comprising 206 final and 21 tentative approvals from the USFDA.

The market for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, is estimated at $96 million for the twelve months ending June 2025, according to IQVIA data. Alembic Pharmaceuticals, an R&D-focused company, has been in the healthcare sector since 1907.