USFDA approves Alembic's Ketorolac tromethamine injection USP

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) 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. This is the second injectable product approved from their General Sterile Facility (F-3) which was inspected in August 2022. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toradol Injection, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, of Roche Palo Alto, LLC (Roche).

Ketorolac Tromethamine is indicated for the short-term (less than five days) management of moderately severe acute pain in adult patients. Ketorolac Tromethamine Injection USP has an estimated market size of US$ 59 million for twelve months ending June 2022 according to IQVIA.