CDSCO Panel Rejects Dr Reddy's Proposal to Study FDC of Ketorolac plus Serratiopeptidase Capsules
New Delhi: Citing there is no rationality of the combination and significant benefits, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the drug major Dr. Reddys Laboratories' proposal to conduct a clinical trial of fixed-dose combination (FDC) Ketorolac Tromethamine 10mg plus Serratiopeptidase 15mg Capsules.
This came after the drug major Dr. Reddys Laboratories presented the medical rationale/justification along with the Phase III clinical trial study protocol and request for bioequivalence (BE) study waiver before the committee.
Ketorolac is a medication used in the management and treatment of acute moderate to severe pain. It is in the nonsteroidal anti-inflammatory drug class.
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).
Serratiopeptidase belongs to the class of drugs known as 'non-steroidal anti-inflammatory drugs' (NSAID). Serratiopeptidase is used in oral surgery for its anti-inflammatory purpose after impaction surgery, maxillofacial trauma, and infections but its use should be limited in cases of abscess due to its fibrinolytic activity.
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