www.fdanews.com/articles/152393-generic-concerta-exclusivity-may-hinge-on-generic-actos-exclusivity
Generic Concerta Exclusivity May Hinge on Generic Actos Exclusivity
January 15, 2013
The FDA may be withholding a final 180-day exclusivity decision for Mallinckrodt’s Concerta generic until an appeals court resolves a legal battle over Actos generics that could dictate what types of regulatory filings lead to an exclusivity reward, a legal expert says.
Washington Drug Letter
Washington Drug Letter