LEXINGTON, Mass.--(BUSINESS WIRE)--May 4, 2006--NitroMed, Inc. (NASDAQ: NTMD - News) said that the U.S. Food and Drug Administration (FDA) issued a letter today confirming that FDA has not approved any drug that is therapeutically equivalent or substitutable to BiDil, the fixed-dose combination of isosorbide dinitrate/hydralazine hydrochloride, approved as adjunct treatment of heart failure in self-identified black patients. Moreover, the FDA confirmed that neither approved labeling for isosorbide dinitrate nor approved labeling for hydralazine hydrochloride contains information regarding the use of these drug products for the treatment of heart failure. The statements contained in the letter are consistent with the FDA's Orange Book and the FDA-approved labeling for BiDil and confirm that the FDA does not consider other drug products to be substitutable for BiDil.
