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  • Title: FDA approves Biaxin for MAC prophylaxis. Food and Drug Administration.
    Journal: J Int Assoc Physicians AIDS Care; 1995 Dec; 1(11):43. PubMed ID: 11363096.
    Abstract:
    In 1995, the Food and Drug Administration (FDA) extended the label use of Biaxin (clarithromycin) to include prophylaxis against disseminated Mycobacterium Avium complex (MAC). Clinical trials demonstrated that clarithromycin decreased the risk of developing disseminated MAC disease in patients with advanced AIDS. A statistically significant survival benefit was also observed. Taste perversion was the only common adverse effect among treated patients. The FDA is considering another Supplemental New Drug Application for clarithromycin in combination with omeprazole for treating Heliobacter pylori.
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