Intuniv guanfacine extended release regulatory update

Actavis Group (Zug, Switzerland) said FDA granted tentative approval of its ANDA for a generic of Shire's ADHD drug Intuniv guanfacine extended release. In 2010, Shire was notified that Actavis, Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) and Anchen Pharmaceuticals Inc. each submitted an ANDA for approval of generic versions of Intuniv. Shire subsequently filed suit in the U.S. District Court for the District of Delaware alleging that the 3 ANDAs infringes on Shire's patents. A trial is scheduled for Sept. 17. ...