WASHINGTON, May 24 (UPI) — The U.S. Food and Drug Administration says Ortho-McNeil Pharmaceutical LLC has been fined $6.14 million under the U.S. Food, Drug & Cosmetic Act.
Friday’s guilty plea and sentencing in Boston U.S. District Court was for illegally marketing the company’s epilepsy drug Topamax for unapproved uses, the FDA said.
The government said Ortho-McNeil promoted Topamax for psychiatric uses, but the FDA never approved the drug to treat any psychiatric disorders.
An affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals Inc. will pay $75.3 million to resolve related civil allegations under the False Claims Act.
Orth-McNeil is a division of Johnson & Johnson Inc.
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