FDA grants extension for approval of pancreatic extract drugs

October 30, 2007

Manufacturers of pancreatic extract drugs can have two more years to obtain approval of their products, thanks to a new FDA notice.

The FDA has extended the time period for manufacturers of exocrine pancreatic insufficiency drugs to obtain approval for their products. These drugs have been sold in this country for many years, predating the 1938 Federal Food, Drug, and Cosmetic Act, so they did not obtain FDA approval before entering the market. The agency had given manufacturers until April 28, 2008, to obtain clearance for their drugs, but some companies told the FDA that they need more time. To ensure that patients have access to these products, the agency is granting a two-year extension-until April 28, 2010. The FDA added that manufacturers must have investigational New Drug Applications filed by April 28, 2008, and must submit New Drug Applications by April 28, 2009. This FDA notice was published in the Oct. 26