Ortho-McNeil Pharmaceutical

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FDA to toughen warnings on migraine drug

The U.S. Food and Drug Administration said it will strengthen warnings on the anti-migraine and anti-seizure treatment Topamax and its generic equivalents after new data suggested a higher risk for cleft palates in babies born to women taking the drug.

The move represents a setback for health-care products giant Johnson & Johnson, which owns Topamax maker Ortho-McNeil Pharmaceutical LLC. The subsidiary last May pleaded guilty to promoting the drug for off-label uses and had to pay an $81.5 million fine. Get the full story »