WEST CHESTER, Pa., May 12 (Reuters) - Cephalon Inc and Chiron Corp CHIR.O said in a statement Tuesday that the U.S. Food and Drug Administration has indicated their new drug application to market a treatment for Lou Gherig's disease is "potentially approvable." Cephalon, which issued the statement, said any approval for its Myotrophin Injection for the treatment of amyotrphic lateral sclerosis, is subject to submission of additional information from ongoing studies demonstrating its effectiveness. "We plan to meet with the FDA to clarify the conditions for approval and to determine whether these conditions can be satisfied," said Dr Frank Baldino Jr, president and chief executive officer of Cephalon, and Dr Lewis Williams, president of Chiron Technologies, a division of Chiron Corp. REUTERS Rtr 00:36 05-13-98
Copyright 1998, Reuters News Service |