The European Medicines Agency said Monday it was notified by Abbott Laboratories Limited of its decision to withdraw its application for a centralized marketing authorization for the medicine Ozespa, briakinumab, 100 mg solution for injection. Get the full story »
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Abbott under FDA scrutiny for psoriasis drug
Abbott Laboratories this morning said it will hold off seeking U.S. approval of an experimental psoriasis treatment following feedback from federal regulators who have concerns about the drug.
Abbott would not disclose exactly what the concerns of the U.S. Food and Drug Administration are. The agency, however, has in recent years stepped up its scrutiny of the safety and efficacy of drugs and increasingly orders more study in clinical trials, particularly for safety risks to the heart.
The news hit the company’s stock. The price of Abbott’s shares lost 1 percent of their value or 49 cents, dipping to $46.88 in trading on the New York Stock Exchange. Get the full story »
