Alembic Pharmaceuticals (Alembic) announced that 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. The approval covers 40 mg/mL Single-Dose Vials, as well as 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 Bristol-Myers Squibb Company. Triamcinolone Acetonide Injectable Suspension USP is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. The label contains detailed indications.
Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, has an estimated market size of US$ 96 million for the twelve months ending June 2025, according to IQVIA.
Alembic now holds a cumulative total of 227 ANDA approvals from USFDA, comprising 206 final approvals and 21 tentative approvals.
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