Executive Summary

Roche asks FDA not to limit proposal on hypnotic relabeling and repackaging to benzodiazepines in a Jan. 15 letter to the agency's Neuropharmacological Drugs Division. Roche, which manufactures Dalmane, was among the companies receiving a Dec. 3 letter from FDA Neuropharmacological Drugs Division Director Paul Leber, MD, asking for relabeling, repackaging, and patient package inserts for all benzodiazepines on the model adopted for Upjohn's Halcion ("The Pink Sheet" Dec. 16, T&G-1). Roche said it also asked FDA to take steps to ensure that all hypnotic manufacturers comply with the agency's request at the same time. In addition, Roche said it expressed its concern that differences between benzodiazepine products, such as half-life and incidence of specific side effects, would be obscured by class labeling....