US FDA set for even fewer approvals in 2008

The US Food and Drug Administration is on course for an even worse level of new drug approvals in 2008 than for last year, according to a report by the Dow Jones. At the end of June, the federal agency had cleared only nine New Molecular Entities and new Biological License Application, a distinct improvement on 2007, when seven were approved, but still behind the 11 recorded in the first-half 2006 (Marketletter July 30, 2007). In July, only one more NME was cleared by the FDA, German drugmaker Bayer HealthCare's Eovist (gadoxetate disodium).

The NMEs given marketing authorization in the first half of 2008 were: Tibotec's Intelence (etravirine); Wyeth's Pristiq (desvenlafaxine succinate); Cephalon's Treanda (bendamustine HCl); CV Therapuetics' Lexiscan (regadenoson); Progenics' Relistor (methylnaltrexone bromide); Adolor's Entereg (alvimopan); and Sirion's Durezol (difluprednate).