American Home Products
This article was originally published in The Gray Sheet
Executive Summary
Use of rhBMP-2 bone morphogenic protein product for long-bone fractures is expected by the firm's Genetics Institute unit to go before FDA's Orthopedics and Rehabilitation Devices Advisory Panel by the end of 2002. The firm received a not-approvable letter for the indication June 22 due to problems with the initial clinical trial design and data interpretation (1"The Gray Sheet" June 25, 2001, p. 27). Stryker's OP-1 will be the first bone morphogenic protein product on the market following humanitarian device exemption clearance for long-bone non-union fractures, announced Oct. 17 (2"The Gray Sheet" Oct. 22, 2001, p. 20). AHP hopes to be on the market in early 2003