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 handed Luitpold Pharmaceuticals a Complete Response Letter (CRL) on its NDA for Injectafer after a recent inspection raised concerns about the drugmaker's Shirley, N.Y. manufacturing facility. Luitpold, which plans to produce Injectafir (ferric carboxymaltose injection) for the U.S. market at the Long Island plant, stressed that the CLR did not include any concerns about its NDA submission. Drug Industry Daily