Abbott Receives FDA Complete Response Letter for Pain Drug
October 21, 2008
US-based healthcare company Abbott Laboratories has received a complete response letter from the FDA for its new drug application for a controlled-release form of hydrocodone with acetaminophen.
Abbott is evaluating the FDA complete response letter. The company said that it will discuss the letter with the FDA and will provide an update when appropriate.
Abbott is seeking the approval of controlled-release hydrocodone with acetaminophen as the first extended release medication in the class to provide extended relief over 12 hours; currently available short-acting hydrocodone and acetaminophen medications must be taken every four to six hours.