Watson Files ANDA with FDA for Generic Daytrana

Watson Laboratories has filed an Abbreviated New Drug Application with the U.S. FDA for the marketing approval of Methylphenidate Transdermal System.

Watson Pharmaceuticals' subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA seeking approval to market Methylphenidate Transdermal System, 10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs, and 30 mg/9 hrs.

Watson's Methylphenidate Transdermal System products are generic versions of Noven Pharmaceuticals, Inc.'s Daytrana(R). Daytrana(R) is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Noven filed suit against Watson on October 13, 2011 in the United States District Court of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Pate