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Columbia Labs Crinone NDA approval, launch anticipated in second quarter, firm tells investors.

Executive Summary

COLUMBIA LABS CRINONE NDA APPROVAL ANTICIPATED IN SECOND QUARTER, Chairman William Bologna told investors Jan. 23 at the American Stock Exchange Health Care Conference in New York. "This product has been given priority rating at the FDA and we have a six-month review" schedule, he said. "We expect approval in the U.S. next quarter." The NDA for Crinone (progesterone) for use in assisted reproductive technology procedures was filed on Nov. 13 and subsequently granted priority review status. The user fee deadline is May 13.
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