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BiDil therapeutic equivalence

Executive Summary

FDA issues a letter May 4 confirming that it "has not approved any drug that is therapeutically equivalent or substitutable to" NitroMed's heart failure therapy BiDil. NitroMed filed a Citizen Petition seeking such confirmation from FDA in an effort to quell reports of the availability of generic versions of the isosorbide dinitrate/hydralazine hyrdrochloride combo product. Both components are generically available...

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