Anesta regulatory update

The FDA's Anesthetic and Life Support Drugs Advisory Committee has completed a review of the controlled roll-out of NSTA's Fentanyl Oralet, a pediatric oral transmucosal version of the anesthetic/pain-killer fentanyl, which was approved in October 1993 for pediatric use under restricted conditions.

Because there have been no significant safety problems, the committee recommended that the agency lift certain restraints on the marketing of the drug by Abbott Laboratories' hospital products division. NSTA said it will meet with Abbott and the FDA in the near future to discuss the recommendations. ...