Crofelemer New Drug Application awaiting approval from USFDA: Salix Pharma

Salix affirmed in its memo, "The FDA continues to work collaboratively with Salix to progress this important product through its full review. By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continue. The continuing dialogue should allow further collaboration between Salix and the Agency, a collaboration that has resulted in substantial progress in handling topics important to crofelemer and botanical products in general. The primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use. This focus is needed to ensure compliance with the manufacturing and product quality requirements of the Food, Drug & Cosmetic Act.”

The company also added “Both Salix and FDA are committed to a robust level of cooperation and data exchange with the goal of providing crofelemer to patients suffering from this very important unmet need. Salix looks forward to this continuing collaboration and anticipate an action by FDA by the end of the first quarter of 2013."