FDA approves 31 NMEs in 2004, 10 more than in 2003The FDA approved 10 more new molecular entities (NMEs) in 2004 than it did the previous year.
With a total of 31 NMEs, the final tally is the single highest count since 1999 when the FDA approved 35 NMEs.
Fallout surrounding the removal of Merck's Vioxx from the market appeared not to affect the number of NMEs approved, with clearance for 14 of the 31 NMEs coming after Merck's Sept. 30 withdrawal of Vioxx from the market.
Eight of the NME approvals came during the last two weeks of the year, when critical publicity over the FDA's regulatory process reached its height.
Pfizer's Lyrica, approved Dec. 30 was the final NME to get the green light in 2004, and represented Pfizer's third NME of the year. The others were Macugen, to be co-marketed with Eyetech, and Spiriva to be marketed jointly with Boehringer Ingleheim.
Aventis received two NME approvals for quick-acting insulin Apidra and antibiotic Ketek.Lilly also received two approvals, for its cancer drug Alimta and antidepressant Cymbalta.
Novartis received one NME approval for its overactive bladder treatment Enablex.
Merck and Johnson & Johnson failed to gain an NME approval
"I don't know if it signals a return to the heady days of the '80s and '90s but obviously the more products there are on the market, the more opportunities there are for agencies to help their clients. Our work is dependent on the number of products on the market," said Jed Beitler, chief executive of Sudler & Hennessey.