Zydus Lifesciences gets FDA final approval for Toradol generic
Zydus Lifesciences Limited (previously Cadila Healthcare Limited) has secured final approval for its analgesic drug Ketorolac Tromethamine Tablets USP, 10 mg from the US Food and Drug Administration (FDA).
The approved product is a generic version of Toradol.
Ketorolac Tromethamine Tablets are approved for their use in easing moderately severe pain, commonly after surgery.
According to Zydus Lifesciences, the analgesic drug will be manufactured at its formulation manufacturing plant at Ahmedabad SEZ, India.
As per IQVIA MAT Aug 2022 data, Ketorolac Tromethamine Tablets had annual sales of $17 million in the US.
Zydus Lifesciences has now taken its approvals to 328 and has so far submitted more than 428 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.