Allergan Again Pressures FDA On Restasis Generics

Law360, New York (August 10, 2017, 6:17 PM EDT) -- Allergan PLC is continuing its push to keep a generic version of the dry-eye blockbuster Restasis off the market by submitting at least its third citizen petition to the U.S. Food and Drug Administration arguing that the agency is letting companies use insufficient studies to prove bioequivalence.

The Aug. 4 petition states that the agency shouldn't approve any generic versions that rely on “in vitro or other nonclinical analyses" as opposed to "one or more appropriately designed clinical endpoint bioequivalence studies." Or put more simply, it...
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