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news.Pfizer has received an approvable letter from the FDA for dalbavancin HCl, a once-weekly two-dose antibiotic for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus.
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The FDA has recently published a draft guidance on studies designed to show non-inferiority as a basis for approval of antibacterial drug products and has requested that Pfizer provide additional data with regard to dalbavancin. Pfizer is working with the FDA to respond to these new requirements.
Separately, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third-party manufacturer, not specifically related to dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues.