McNeil Rx Nicotrol Inhaler has six-month limit to recommended treatment duration.
This article was originally published in The Tan Sheet
Executive Summary
MCNEIL NICOTROL INHALER Rx TREATMENT DURATION IS SIX MONTHS, the company said following FDA approval of the nicotine inhalation system May 2. "After initial treatment period (up to 12 weeks), the patient is recommended to begin a gradual reduction of dosage. Total treatment should not exceed six months," the Johnson & Johnson subsidiary said. FDA approval came one year after the NDA was submitted on May 1, 1996.