Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) 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.

Notably, this is the second injectable product approved by the company's General Sterile Facility (F-3) which was inspected in August 2022.

 In a regulatory filing, the company stated, "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 (≤5 days) management of moderately severe acute pain in adult patients. Refer to our label for full indication."

Alembic has a cumulative total of 175 ANDA approvals (151 final approvals and 24 tentative approvals) from the US FDA.