Allergan Petitions FDA to Tighten Bioequivalence Requirements
Allergan called on the FDA not to approve any ANDAs for cyclosporine ophthalmic emulsion that do not prove bioequivalence through clinical endpoint studies.
In a citizen petition, the drugmaker called on the agency to reject all ANDAs that reference Restasis – Allergan’s cyclosporine ophthalmic emulsion product -- but don’t include at least one clinical endpoint study.
The petition also urged the agency not to approve such ANDAs until at least 60 days after it issues final guidance on testing requirements for cyclosporine ophthalmic emulsion, as well as guidelines for evaluating and approving generics for nonbiological complex drugs.
Allergan also called for an explanation of “inconsistent claims” the agency has made regarding reliance on research featuring products other than cyclosporine ophthalmic emulsion in proving bioequivalence.