- Allergan (AGN -2%) is out defending Restasis in the face of FDA draft guidance issued in June which said in vitro analysis would be sufficient to establish bioequivalence.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