Alembic gets USFDA nod for generic pain-relief medication

The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ketorolac Tromethamine Injection In multiple strengths, the drug maker said in a statement.

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Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market Ketorolac Tromethamine Injection, used to treat moderate to severe pain, in the American market.

The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ketorolac Tromethamine Injection In multiple strengths, the drug maker said in a statement.

“This is the second injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022,” it added.

The company’s product is therapeutically equivalent to Roche Palo Alto LLC’s Toradol Injection.

Ketorolac Tromethamine is indicated for the short-term management of moderately severe acute pain in adult patients.

According to IQVIA data, Ketorolac Tromethamine Injection USP has an estimated market size of USD 59 million in the US.