In Brief: Abbott's Biaxin
Abbott's Biaxin: Clarithromycin receives supplemental NDA approval Oct. 12 for prevention of disseminated Mycobacterium avium complex in people with advanced HIV. Biaxin is already approved for treatment of MAC. Pharmacia's Mycobutin (rifabutin) was the first drug to receive FDA clearance for prevention of the opportunistic infection. FDA notes that unlike Mycobutin, clarithromycin patients with MAC taking 500 mg twice-daily had a statistically significant survival benefit compared to placebo. The supplemental NDA was filed April 17...
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