US FDA Approving Fewer NMEs, But Faster, In 1995

During the first eight months of 1995, the US Food and Drug Administration approved 11 New Molecular Entities in an average time of 18.2 months. By the end of the first eight months of 1994, 12 NMEs had been approved, but with a longer approval time, averaging 19.7 months.

Review time for the NMEs approved so far has averaged 16.5 months, with the time taken by manufacturers to respond averaging 4.5 months.

Three of the NMEs approved so far this year initially received "not approvable" letters from the agency, and the final approval time for these averaged 23 months. One of these products, Berlex' Ultravist (iopramide), received the lengthiest review of all 11 NMEs approved so far this year, at 25.7 months. The shortest approval time so far has been for Hoffmann-La Roche/Syntex' Cellcept (mycophenolate mofetil), at 5.7 months, and one product, Pharmacia's Zinecard (dexrazoxane) received a priority review, reaching approval in 9.7 months.