A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees.
The FDA has approved Eisai’s Fycompa tablets to treat partial-onset seizures in epilepsy patients ages 12 and older. Partial seizures are the most common type of epileptic seizure and some patients do not get satisfactory control from current treatments, Russell Katz, director of CDER’s Division of Neurology Products, said Monday. “It is important to have a variety of treatment options available for patients with epilepsy.” Drug Industry Daily