Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL Single-Dose Vials, 200 mg/5 mL and 400 mg/10 mL (40 mg/mL) Multiple-Dose Vials.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Kenalog-40 Injectable Suspension, of BristolMyers Squibb Company.

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. Refer label for a detailed indication.

Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA.

Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, has an estimated market size of US$ 96 million for twelve months ending June 2025 according to IQVIA.