FDA re-instates Ferring's Repronex ANDA approval following appellate court decision.
Executive Summary
FERRING REPRONEX ANDA APPROVAL REINSTATED BY FDA Aug. 12 following a U.S. appellate court decision to stay a lower court injunction that had barred Ferring from marketing of the menotropins product. FDA had notified Ferring July 29 that it had suspended Repronex approval in response to a preliminary injunction by the D.C. federal court. Serono, manufacturer of the innovator menotropins product Pergonal, filed suit on May 30 against FDA seeking to revoke approval of the generic ("The Pink Sheet" Aug. 4, T&G-9).