Allergan wants FDA to take a closer look at Restasis draft guidance

|About: Allergan plc (AGN)|By:, SA News Editor

Allergan (AGN -2%) is out defending Restasis in the face of FDA draft guidance issued in June which said in vitro analysis would be sufficient to establish bioequivalence.

AGN "respectfully" disagrees, calling the regulator's proposal "unsound both scientifically and legally."

In short, AGN wants generics tested in patients rather than just in the lab, which would fend-off competition for the drug which generated nearly $800M in revenue in 2012. (full letter)

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