FDA approves Watson pain patch
PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.
Watson announced the approval of lidocaine topical patch in the 5% strength. The drug is a generic version of Endo Pharmaceuticals' Lidoderm, which had sales of about $1.2 billion during the 12-month period ended in June 2012, according to IMS Health.
Watson said it plans to launch the drug in September 2013 under an agreement with Endo and Teikoku Seiyaku Co. and, as the presumed first company to successfully file for FDA approval, will likely receive 180 days of market exclusivity in which to compete directly with the branded version.