February FDA news in review

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There were several notable FDA approvals in February. First, the FDA approved GTC Biotherapeutics' ATryn, marking the first time the agency has OK'd a transgenic therapy--drugs developed in genetically engineered animals. ATryn is made from the milk of genetically engineered goats. The FDA also approved the first new gout drug in 40 years. Takeda's Uloric treats the painful effects of a buildup of uric acid in the blood and soft tissues, a condition which plagues five million Americans.

Finally, Eli Lilly and Daiichi Sankyo are anticipating FDA approval of the blood thinner prasugrel after the agency's cardiovascular committee unanimously recommended approval of the potential blockbuster. (The panel did not include noted cardiologist Sanjay Kaul, which has caused a separate set of problems for Lilly). FDA watchers say the recommendation could signal a change at the cautious FDA. Prasugrel was found to be more effective than Plavix in studies, but also increased the risk of serious bleeding incidents. If the drug is approved, the FDA may require special labeling for prasugrel to make sure it's used by patients who are less likely to have an adverse reaction to the drug. The EMEA has already given final approval of the drug.

What's new at the FDA

  • Stimulus gives $1.1B to comparative studies

  • $1.15B project allows FDA to centralize

  • Prasugrel vote will signal FDA's stance

  • Does Yaz correction signal a DTC shift?

  • Obama: FDA due for 'complete review'

  • FDA erred in excluding expert from review

Safety, Warnings and Recalls

  • FDA warned tainted syringe maker

  • FDA: Eisai drug increases acidosis risk

  • FDA backed off device lab inspections

  • FDA says Ranbaxy faked drug data

  • FDA slaps restrictions on painkillers


FDA Approvals

  • FDA approves first gout drug in 40 years

  • FDA panel narrowly votes in favor of Dyax drug

  • Sanofi gains approval for Apidra insulin, Intanza vax

  • FDA approves GTC's transgenic drug ATryn

  • Lilly gets unanimous vote in favor of prasugrel

FDA Delays

  • FDA seeks more telavancin data

  • Hemispherx plays the FDA waiting game

  • Savient gout drug faces approval delay

  • FDA denies approval for sleep drug

  • FDA delays extra indication for J&J's Risperdal

  • Teva's laquinimod for MS gets fast tracked


February FDA news in review
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