Zydus bags USFDA final approval for Ketorolac Tromethamine Tablets

25 Oct 2022 , 10:07 AM

Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Ketorolac Tromethamine Tablets USP, 10 mg (USRLD: Toradol).

According to the regulatory filing, Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Ketorolac Tromethamine Tablets had annual sales of USD 17mn in the United States according to IQVIA data (IQVIA MAT Aug 2022).

The group now has 328 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

At around 10:07 AM, Zydus Lifesciences Ltd is currently trading at Rs412 per share down by Rs1.15 or 0.28% from its previous closing of Rs413.15 per share on the BSE.

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