US FDA approves Ketorolac Tromethamine injection by Alembic Pharma
This is the second injectable product approval from the company's General Sterile Facility (F-3) which was inspected in August, 2022
The US Food and Drug Adminisration (FDA) has given final approval to Alembic Pharma’s 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, a statement from Alembic Pharma notified.
This is the second injectable product approval from the company’s General Sterile Facility (F-3) which was inspected in August, 2022, according to the satement.
It also said that the approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Toradol injection, 15 mg/mL, 30 mg/mL and 60 mg/2 mL, of Roche Palo Alto.
Further, as per the statement, Ketorolac Tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients.
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