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Pfizer has announced it has received an approvable letter from the Food and Drug Administration (FDA) for a drug to combat methicillin-resistant Staphylococcus aureus (MRSA).
Dalbavancin is a once-weekly two-dose antibiotic currently being reviewed by the FDA for the treatment of adult patients with complicated skin infections such as MRSA.
The FDA has how requested that the company hands over additional data with regard to the drug, and Pfizer is working with the regulator to provide this.
In a separate move, the FDA’s letter also refers to issues surrounding manufacturing practices at a third-party factory, although these are not related to dalbavancin.
Pfizer said the manufacturer is working with the FDA to resolve the outstanding problems around the drug-making process.
A statement added that the firm is also addressing a question from the FDA regarding length of storage time following reconstitution of dalbavancin.
Dalbavancin is a member of the glycopeptide class of antibiotics, and was bought by Pfizer in September 2005 as part of its buyout of Vicuron Pharmaceuticals.
Pfizer already makes the FDA-approved drug Zyvox (linezolid IV/Oral) for the treatment of complicated skin and skin structure infections caused by MRSA.
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