Alembic Pharmaceuticals Limited announced on Thursday that it has received final approval from the US Food and 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, the company said in a statement.
This is the second injectable product approval from our 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 (Roche). Ketorolac Tromethamine is indicated for the short-term ( more than or equal to 5 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, the statement by the company read.