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Verex Labs

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Executive Summary

ANDA suitability petition for indomethacin constant-release 75 mg tabs was denied by FDA. Verex had filed the petition in January. FDA Office of Drug Standards Div. Director Peter Rheinstein told the firm that investigations are needed to show the safety and efficacy of the proposed product because its "controlled-release mechanism differs significantiy from" the referenced product Indocin SR. Rheinstein explained that "Indocin SR is not a constant release product as referred to in your petition," because if "has kinetic characteristics such that it releases 25 mg of indomethacin initially and then subsequently releases 50 mg more".

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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