Alembic Pharmaceuticals has secured final approval from the US Food & Drug Administration (USFDA) for its Triamcinolone Acetonide Injectable Suspension USP. This covers 40 mg/mL single and multiple-dose vials. The product is therapeutically equivalent to Kenalog-40 and addresses conditions where oral therapy is unsuitable. As of June 2025, the market size for this injection is estimated at US$ 96 million.
USFDA Approval Details
Alembic Pharmaceuticals Limited announced it has received final USFDA approval for Triamcinolone Acetonide Injectable Suspension USP, in 40 mg/mL single-dose vials, 200 mg/5 mL and 400 mg/10 mL multiple-dose vials. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Bristol-Myers Squibb Company’s Kenalog-40 Injectable Suspension.
Therapeutic Use
Triamcinolone Acetonide Injectable Suspension USP is prescribed for autoimmune, inflammatory, and other conditions where oral treatment is not feasible. Detailed indications should be obtained from the product label.
Alembic’s ANDA Approvals
With this approval, Alembic Pharmaceuticals now holds a cumulative total of 227 ANDA approvals. This total includes 206 final approvals and 21 tentative approvals from the USFDA.
Market Size
The market size for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, is estimated at approximately US$ 96 million for the twelve-month period ending June 2025, as per IQVIA data.
Source: BSE
