The Wall Street Journal-20080201-In Brief

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In Brief

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Medicis Antiwrinkle Drug

Faces Regulatory Setback

Reloxin, a drug under development by Medicis Pharmaceutical Corp. that could be the first U.S. rival for Allergan Inc.'s antiwrinkle drug Botox, has experienced a regulatory setback likely to delay its launch until next year. Medicis in December submitted a Reloxin marketing application to the Food and Drug Administration. In a Securities and Exchange Commission filing, Medicis said "the FDA has determined not to accept the Biologics License Application for filing because it is not sufficiently complete to permit a substantive review."

FDA Says 11 Drugs Tied

To Higher Suicide Risk

The Food and Drug Administration warned patients and health-care professionals about an increased risk of suicidal thoughts and behaviors associated with 11 drugs used to treat epilepsy and certain psychiatric disorders. The drugs include Topamax by Johnson & Johnson, Lamictal by GlaxoSmithKline PLC, Pfizer Inc.'s Lyrica and Neurontin, and Novartis AG's Tegretol and Trileptal. Pfizer said it hasn't identified evidence of an increased risk of suicide-related events in Lyrica or Neurontin. Glaxo said it would work with the FDA to update Lamictal's label if needed, and Johnson & Johnson said there is a discussion about suicide attempts in the Topamax label. Novartis didn't return requests to comment.