FDA proposed antibacterial rule
This article was originally published in Pharmaceutical Approvals Monthly
The agency proposed Sept. 19 that labeling for all systemic antibacterial drugs contain information about appropriate use of antimicrobials in order to help curb the emergence of drug-resistant bacterial strains. FDA Commissioner Jane Henney, MD, pointed out at a Sept. 20 Senate subcommittee hearing that Pharmacia's recently approved Zyvox (linezolid) "has some of this language in its package labeling." FDA is considering a drug exclusivity program to encourage microbial product development, which could be modeled after the agency's existing exclusivity program for orphan-designated drugs or pediatric products, she sai
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