SK&F's Stelazine
Executive Summary
FDA announced in the Dec. 13 Federal Register that the drug (trifluoperazine HCl) is DESI-effective for short-term treatment of generalized nonpsychotic anxiety. Conclusion was based on a four-week double-blind parallel multicenter study involving 11 independent investigators and 415 patients. Agency-approved labeling states that Stelazine is "not the first drug to be used" for the indication "because certain risks associated with its use are not shared by" benzodiazepines.