Serono files Pergonal suit against FDA to reverse approval of Ferring generic menotropins.

Executive Summary

SERONO MENOTROPINS SUIT DEMANDS REVERSAL OF FERRING ANDA APPROVAL for a generic version of Pergonal. Serono v. Shalala and Friedman was filed by Serono attorneys Fox Bennett & Turner in Washington, D.C. District Court on May 30. The suit alleges that "FDA relied on Serono's injectable menotropins product for infertility -- Pergonal -- in approving the Ferring ANDA, even though the active and inactive ingredients in Pergonal are different from the ingredients in the Ferring generic product." FDA approved the Ferring NDA on Jan. 30.