Unapproved analgesic sales stopped. (Esgic with Codeine)

FDA Consumer | April 1, 1990| | Copyright

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 ...

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