Smoking Cessation Label Changes Could Lay Groundwork For Indications

08 Apr 2013

• By Lisa Gillespie and Malcolm Spicer

FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.

FDA will allow OTC nicotine replacement therapy products to drop duration-of-use limits and warnings about concomitant use with other cessation products from labeling, laying potential groundwork for eventual expansion of NRT indications.

However, the agency denied requests to expand NRT indications, made in multiple citizen petitions, in a letter released...