Pfizer MRSA antibiotic considered "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer may have to justify use of non-inferiority trials as a basis for approval for the firm's antibiotic dalbavancin, under review for complicated skin and skin structure infections such as those caused by methicillin-resistant Staphylococcus aureus. Pfizer, which received an "approvable" letter Dec. 21, is working with FDA to resolve concerns over good manufacturing practices, length of storage time and other "open issues"...
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Pfizer may have to justify use of non-inferiority trials as a basis for approval for the firm's antibiotic dalbavancin, under review for complicated skin and skin structure infections such as those caused by methicillin-resistant Staphylococcus aureus. Pfizer, which received an "approvable" letter Dec. 21, is working with FDA to resolve concerns over good manufacturing practices, length of storage time and other "open issues".... |