Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Ketorolac Tromethamine Tablets USP, 10 mg.
Ketorolac Tromethamine Tablets are approved to alleviate moderately severe pain, typically following surgery, claims the regulatory filing. The group’s formulation manufacturing facility in Ahmedabad SEZ, India, will produce the medication.
Since the filing procedure began in FY 2003–2004, the group has received 328 approvals and has submitted over 428 ANDAs.