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Allergan to challenge proposed FDA bioequivalence guidelines
The U.S. Food and Drug Administration issued new and revised bioequivalence guidelines that may expedite the review and approval of generic versions of cyclosporine ophthalmic suspension and other agents.Allergan, manufacturer of Restasis (cyclosporine ophthalmic emulsion 0.05%), plans to inform the FDA of its disagreement with the guidelines, according to a company spokesperson.