Healthcare Industry News: ACE inhibitor
News Release - May 4, 2006
FDA Confirms No Drugs are Therapeutically Equivalent to BiDil(R)
LEXINGTON, Mass.--(HSMN NewsFeed)--May 4, 2006--NitroMed, Inc. (NASDAQ: NTMD ) 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.The letter written by FDA was initiated by a Citizen Petition from NitroMed for confirmation on the substitution status for BiDil. NitroMed sought confirmation in an effort to address anecdotal reports that information is being disseminated regarding the availability of substitutable or "generic" versions of BiDil.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is an emerging pharmaceutical company and the maker of BiDil® (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine available in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as ACE inhibitors and/or beta blockers. There is little experience in patients with New York Heart Association class IV heart failure. BiDil was approved in June 2005 by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company's landmark African American Heart Failure Trial (A-HeFT), and since July 2005, has been marketed by NitroMed through a nationwide, dedicated contract sales force.
For full prescribing information, visit: www.BiDil.com.
BiDil is a registered trademark of NitroMed, Inc.
Source: NitroMed
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