New drug and biological product approvals, 2009

Thirty-seven new molecular entities, vaccines, and blood products won FDA marketing approval last year, up from 34 in the previous year. Highlights of the approved products appear below, and a full list of new products and their indications appears on page 256. A reformulated version of Creon pancrelipase oral capsules from Solvay Pharmaceuticals was approved in April, making the product the only FDA-sanctioned prescription pancreatic enzyme replacement product on the U.S. market. Creon is indicated for the treatment of exocrine pancreatic insufficiency in people with cystic fibrosis or other conditions. Pancreatic enzyme replacement products have been sold for decades without FDA’s review and approval of the formulations. FDA announced in 2004 that all makers of unapproved pancreatic insufficiency products, except for dietary supplements, must submit marketing applications to the agency or pull the medications from the market. Manufacturers have until April 28 to earn FDA approval for their current pancrelipase products.