FDA Confirms No Drugs are Therapeutically Equivalent to BiDil(R)

NitroMed, Inc. (NASDAQ: NTMD) said that the U.S. Foodand Drug Administration (FDA) issued a letter today confirming thatFDA has not approved any drug that is therapeutically equivalent orsubstitutable to BiDil, the fixed-dose combination of isosorbidedinitrate/hydralazine hydrochloride, approved as adjunct treatment ofheart failure in self-identified black patients. Moreover, the FDAconfirmed that neither approved labeling for isosorbide dinitrate norapproved labeling for hydralazine hydrochloride contains informationregarding the use of these drug products for the treatment of heartfailure. The statements contained in the letter are consistent withthe FDA's Orange Book and the FDA-approved labeling for BiDil andconfirm that the FDA does not consider other drug products to besubstitutable for BiDil.

The letter written by FDA was initiated by a Citizen Petition fromNitroMed for confirmation on the substitution status for BiDil.NitroMed sought confirmation in an effort to address anecdotal reportsthat information is being disseminated regarding the availability ofsubstitutable or "generic" versions of BiDil.

About NitroMed, Inc.

NitroMed of Lexington, Massachusetts is an emerging pharmaceuticalcompany and the maker of BiDil(R) (isosorbide dinitrate/hydralazinehydrochloride), an orally administered medicine available in theUnited States for the treatment of heart failure in self-identifiedblack patients. In this population, BiDil is indicated as an adjunctto current standard therapies such as ACE inhibitors and/or betablockers. There is little experience in patients with New York HeartAssociation class IV heart failure. BiDil was approved in June 2005 bythe U.S. Food and Drug Administration, primarily on the basis ofefficacy data from the Company's landmark African American HeartFailure Trial (A-HeFT), and since July 2005, has been marketed byNitroMed through a nationwide, dedicated contract sales force.

For full prescribing information, visit: www.BiDil.com.

BiDil is a registered trademark of NitroMed, Inc.