Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: TUESDAY, July 20, 1993 TAG: 9307200110 SECTION: BUSINESS PAGE: B-5 EDITION: STATE SOURCE: DATELINE: WASHINGTON LENGTH: Short
The company and the FDA still need to negotiate what the drug's label can say and in which category of anti-depressants it should be classified, agency spokeswoman Susan Cruzan said Monday.
The Psychopharmachological Drugs Advisory Committee, which recommended approval for the drug nefazodone hydrochloride, had some safety concerns about how it reacts with other drugs, especially the sleeping drug Halcion, Cruzan said.
The drug is supposed to relieve depression by elevating levels of serotonin in the brain, said a statement by Bristol-Myers Squibb Co., which plans to market the drug under the brand name Serzone.
The company would not elaborate on the drug's action or what comparable products already are on the market.
The advisory committee's action is not binding on the FDA, but the agency usually follows such advice. - Associated Press
by CNB