Alembic Pharmaceuticals gets FDA final approval for Ketorolac Tromethamine

Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials from the US Food and Drug Administration (FDA).

The product is the generic version of Roche’s Toradol Injection, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL.

Ketorolac Tromethamine has approval to be used for the short-term (≤five days) management of moderately severe acute pain in adults.

According to IQVIA, for the 12 months ending June 2022, the estimated market size of Ketorolac Tromethamine Injection USP in the US is $59 million.

Ketorolac Tromethamine is the second injectable product approval for Alembic Pharmaceuticals from its F3 general sterile facility (F-3), which was inspected by the FDA in August 2022.

Earlier this week, Alembic Pharmaceuticals bagged final approval for its abbreviated new drug application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.