Pharmacia Says FDA Rejected Application
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Pharmacia Corp. said the Food and Drug Administration rejected its application for an injectable painkiller designed to reduce the need for morphine. The FDA cited “deficiencies” in the company’s application for approval of the drug, which would have been used in hospitals to treat patients who had surgeries such as hip replacements, a Pharmacia spokesman said.
Pharmacia said it will conduct new studies to collect an unspecified amount of data requested by the FDA within 18 months. The drug, parecoxib sodium, would be the first injectable form of the powerful Cox-2 inhibitor class of painkillers. Pharmacia’s Celebrex and Merck & Co.’s Vioxx are the best known members of that class.
Pharmacia shares fell as low as $43 in after-hours trading. The shares rose 63 cents to $46.85 in regular trading on the New York Stock Exchange.
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