Nicotrol NS post-marketing surveillance will be reviewed by an advisory committee.

MCNEIL NICOTROL NS PHASE IV SURVEILLANCE WILL BE REVIEWED BY ADVISORY CMTE., FDA's March 22 approval letter for the nicotine nasal spray states. The agency requests that McNeil Consumer Products, which will market the drug under a license from Pharmacia & Upjohn, implement a marketing and surveillance plan to track the occurrence of off-label use, extended use or abuse; pediatric accidental exposures and any related toxicities; and "unexpected adverse events such as oronasopharyngeal injury associated with long-term use," FDA writes in the approval letter.