Petition Seeking Tighter Restasis ANDA Bioequivalence Denied

FDA has denied an Allergan citizen petition that had asked the agency not to approve ANDAs for Restasis (cyclosporine ophthalmic emulsion) unless certain conditions are met. The petition had asked that FDA, among other things, not approve such ANDAs if they only contain in vitro demonstrations of bioequivalence.



In its denial letter, the agency said that as long as the generic product has the same qualitative and quantitative composition as the reference-listed drug (RLD) and its physiochemical properties and in vitro drug release characteristics are also comparable to the RLD, then in vitro testing should suffice to demonstrate bioequivalence. FDA says this method is acceptable regardless of whether there are established in vitro-in vivo correlations for the measured physiochemical properties or in vitro drug release characteristics.