Mylan Pharmaceuticals has filed suit against FDA seeking to overturn a decision that gives Teva Pharmaceuticals 180-day exclusivity to market the generic version of its affiliate Cephalon's Provigil.
Mylan alleges Teva did not keep up valid paragraph IV certifications as a result of its purchase of Cephalon and the FDA should have found Mylan as the sole first filer on one of the patents for Provigil.
The complaint alleges that FDA's decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful.
Mylan is seeking an immediate Court order entitling it to exclusivity and approval for its ANDA.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/mylan-files-suit-against-fda-to-overturn-provigil-decision-060412
