Institut Biochimique SA (IBSA): diclofenac epolamine

Act for diclofenac epolamine topical system 1.3%.

Conduct at least one adequate and well-controlled clinical efficacy trial to demonstrate the safety and effectiveness of the to-be-marketed product manufactured at the proposed commercial manufacturing site, We recommend that you discuss the design of this study with the Division in advance.

The approach for toxicological evaluation of the safety of leachables must be based on good scientific principles and take into account the drug product formulation, dosage form, route of administration, and dose regimen (chronic or short-term dosing).