By Blumenthal, Dale
FDA Consumer , Vol. 24, No. 3
The federal government has told a drug manufacturer to stop selling a prescription painkiller because it is an unapproved new drug.
The analgesic, Esgic with Codeine, manufactured by Forest Pharmaceuticals, Inc., St. Louis, Mo., contains acetaminophen, caffeine, codeine, and butalbital (a barbiturate). Although FDA has approved each of these drugs individually, their combination in one product constitutes a new drug. Under FDA regulations, a new drug can't be marketed until the company submits-and FDA approves-a new drug application.
Forest Pharmaceuticals never sought or received approval for Esgic with Codeine, which the company began selling on April 15, 1987.
FDA immediately advised Forest to take Esgic with Codeine off the market. When Forest didn't comply, the agency considered requesting permission from federal court to seize the product, but delayed acting pending the outcome of a similar case involving the drug Fiorinal with Codeine No. 3. Manufactured by Sandoz Pharmaceuticals, Inc. …