Hoechst-Roussel Altace adds indication for reduced risk of death in CHF immediately following acute MI.
HOECHST-ROUSSEL ALTACE GAINS NEW INDICATION FOR DECREASED RISK OF DEATH when used to treat congestive heart failure immediately following myocardial infarction. Hoechst-Roussel submitted the supplemental NDA (19-901/S-010) in July 1994 with additional supplements in March and April 1995; the indication was declared "approvable" May 26 and was approved Aug. 22. Two amendments dated July 24 and comprising the final printed labeling and updated safety information preceded approval. The angiotensin-converting enzyme inhibitor ramipril previously was approved only for treatment of hypertension.
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