Medications that got the FDA's okay in 2007 included GlaxoSmithKline's Tykerb for breast cancer victims and Novartis AG's Tasigna for leukemia patients. As of November 14 drugs were approved by the FDA, while three more were added in December.
Kenneth Kaitin, director of Tufts University Center for the Study of Drug Development, said pharmaceutical firms are resuming developing new treatments and the number of new approvals should go up in the coming years.
"They got away from their core mission, which was to bring new medicines and new treatments to market," Kaitin told Bloomberg. He explained, "If you're putting money into extending the lifecycle of a drug on the market, you're taking money away from a drug development program."
FDA deputy commissioner Janet Woodcock, in an email response to Bloomberg, said marketing applications for new medication has gone done the past years. The lesser number of applications allowed the FDA to concentrate on analyzing better data on potential safety problems, specially drugs for chronic conditions that patients have to take certain drugs for a lifetime.
Because of the FDA's stricter implementation of safety guidelines, Sanofi-Aventis withdrew its application for the obesity pill Zimulti, while the FDA thumbed down Novartis' painkiller Prexige.
Meanwhile, the FDA approved on Thursday a new test developed by the Toronto-based Luminex Molecular Diagnostics. The xTAG Respiratory Viral Panel can quickly identify in hours what kind of virus is causing a patient to be sick, specifically 12 respiratory viruses including various kinds of influenza and rhinovirus which causes the common cold.
Mark Kolins, chief of Clinical Pathology and medical director at the Beaumont Reference Laboratory, said by identifying early enough the virus, doctors will not make the mistake of prescribing antibiotics for viruses. Only bacteria responds to antibiotics, not viruses.
