ARTICLE | Clinical News

Vycavert hydrocodone bitartrate/acetaminophen regulatory update

September 29, 2014 7:00 AM UTC

On Sept. 15, Acura said it submitted a formal dispute resolution request to FDA for Vycavert, the biotech's abuse-deterrent formulation hydrocodone bitartrate and acetaminophen to treat pain. The biotech said the dispute pertains to the agency's determination that nasal snorting abuse of hydrocodone with acetaminophen products "lacks relevance," thus making Vycavert ineligible for abuse deterrent labeling regardless of its abuse-deterrent profile. The biotech said FDA guidance stipulated that the agency must respond within 30 days. ...