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.
Ranbaxy has begun marketing an authorized generic of Daiichi Sankyo’s dry-mouth treatment Evoxac in the U.S. per an agreement with the Japanese drugmaker. A generic version of Evoxac (cevimeline HCl) was also brought to market by Apotex this quarter following a patent settlement with Daiichi. Generic Line