Alembic Pharmaceuticals gets FDA final approval for Ketorolac Tromethamine

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Alembic Pharmaceuticals has secured final approval 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 from the (FDA).

The product is the generic version of ‘s Toradol Injection, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL.

Ketorolac Tromethamine has approval to be used for the short-term (≤five days) management of moderately severe acute in adults.

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According to IQVIA, for the 12 months ending June 2022, the estimated market size of Ketorolac Tromethamine Injection USP in the US is $59 million.

Ketorolac Tromethamine is the second injectable product approval for from its F3 general sterile facility (F-3), which was inspected by the FDA in August 2022.

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Earlier this week, Alembic Pharmaceuticals bagged final approval for its abbreviated new drug application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.


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