Ferring menotropins ANDA approval rescinded July 29 following court ruling in favor of Serono.

Executive Summary

FERRING MENOTROPINS ANDA APPROVAL SUSPENDED BY FDA JULY 29 following a July 28 ruling by Washington, D.C. federal court Judge Stanley Sporkin in favor of Pergonal manufacturer Serono Labs. Ferring estimated that it has shipped approximately 100,000 vials of the infertility treatment menotropins under the brand name Repronal. FDA approved the ANDA for Repronal Jan. 30 ("The Pink Sheet" Feb. 3, T&G-14). As a result of the July 28 preliminary injunction, "FDA considers any menotropins for injection manufactured pursuant to the above referenced ANDAs, and on the market pursuant to FDA's Jan. 30, 1997, approval letter to be an unapproved new drug," the agency told Ferring.