NitroMed: FDA confirms no equivalent to BiDil

By Lisa Kerner

Erie, Pa., May 4 - The Food and Drug Administration confirmed in a letter that it has not approved any drug that is therapeutically equivalent or substitutable to NitroMed, Inc.'s BiDil, the fixed-dose combination of isosorbide dinitrate/hydralazine hydrochloride approved as adjunct treatment of heart failure in self-identified black patients.

In addition, 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, according to a company news release.

NitroMed said the statements contained in the letter are consistent with the FDA's Orange Book and the FDA-approved labeling for BiDil.

The company said it sought the FDA's confirmation to address anecdotal reports of the availability of substitutable or generic versions of BiDil.

NitroMed is an emerging pharmaceutical company located in Lexington, Mass.

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