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AstraZeneca Merrem I.V. sNDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca submits supplement July 28 for use of its broad-spectrum carbapenem antibiotic Merrem I.V. (meropenem) to treat complicated skin and skin structure infections. The submission is supported by a 1,076-patient Phase III trial in a range of infection types, as well as a pharmacokinetic study. Merrem is approved for treatment of intra-abdominal infections and bacterial meningitis...





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