Medco Research BiDil (hydralazine/isosorbide dinitrate) not recommended for approval -- FDA committee.
Executive Summary
MEDCO RESEARCH CONSIDERING WHETHER TO CONTINUE BIDIL DEVELOPMENT following an unfavorable review by FDA's Cardiovascular & Renal Drugs Advisory Committee at its Feb. 27 meeting. The committee voted 9-3 against recommending approval of the hydralazine/isosorbide dinitrate combination therapy for use in the treatment of congestive heart failure. Following the meeting, the company said that "our plans for BiDil will certainly depend upon whether we believe the specific concerns of the committee and the division are surmountable at a reasonable continued investment by the company."