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FDA Premarket Approval: Process of Approving Lodine as a Drug

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Report Type Reports and Testimonies
Report Date April 12, 1993
Report No. HRD-93-81
Subject
Summary:

Wyeth-Ayerst Laboratories was granted a patent for Lodine in February 1978. Although originally intended to expire in February 1995, the patent expiration date was extended until February 1997. Wyeth-Ayerst is attempting to have a private bill passed by Congress that would extend the Lodine patent beyond 1997 because the company believes that the length of time needed to obtain premarket approval by the Food and Drug Administration was excessive. Wyeth-Ayerst contends that the 97-month period taken by FDA to grant approval deprived the company of a substantial period of patent protection. This report reviews the events surrounding the approval of Lodine and clarifies the related circumstances.

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