Dr. Reddy's Laboratories gets CDSCO Panel Nod for BA/BE study of Ketorolac Tromethamine Sustained Release Tablet

New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Bioavailability/Bioequivalence studies (BA/BE study) of nonsteroidal anti-inflammatory drug Ketorolac Tromethamine Sustained Release Tablet 30 mg for export purpose only.

This came after Dr. Reddy's Laboratories presented the proposal along with a justification of study design about the comparability of the pharmacokinetics of immediate release vs sustained release dosage form with supportive documents before the committee.

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

The primary mechanism of action responsible for ketorolac's anti-inflammatory, antipyretic, and analgesic effects is the inhibition of prostaglandin synthesis by competitive blocking of the enzyme cyclooxygenase (COX). Ketorolac is a non-selective COX inhibitor. It is considered a first-generation nonsteroidal anti-inflammatory drug (NSAID).

At the recent SEC meeting for analgesic and rheumatology held on 2nd May 2024, the expert panel reviewed the proposal along with the justification of the study design with regard to the comparability of the pharmacokinetics of immediate release vs sustained release dosage form with supportive documents before the committee.

After detailed deliberation, the committee recommended the grant of permission to conduct the BA/BE study for export purposes only.

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