FDA Confirms No Drugs are Therapeutically Equivalent to BiDil(R).LEXINGTON, Mass. -- NitroMed, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : NTMD) said that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. , approved as adjunct treatment of heart failure in self-identified black patients. Moreover, the FDA confirmed that neither approved labeling for isosorbide dinitrate i·so·sor·bide di·nit·rate n. A nitrate vasodilator drug administered orally and sublingually for the treatment and prevention of angina pectoris. nor approved labeling for hydralazine hydrochloride hydralazine hydrochloride Apo-Hydralazine (CA), Apresoline, Novo-Hylazin (CA), Nu-Hydral (CA) Pharmacologic class: Peripheral vasodilator Therapeutic class: Antihypertensive Pregnancy risk category C 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(R) (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 Beta Blockers Definition Beta blockers are medicines that affect the body's response to certain nerve impulses. This, in turn, decreases the force and rate of the heart's contractions, which lowers blood pressure and reduces the heart's demand for . There is little experience in patients with New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of 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. |
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