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Home Industry News Pfizer sees Dalbavancin receive approval letter

Pfizer sees Dalbavancin receive approval letter

27th December 2007

Pfizer has confirmed that the US Food and Drug Administration (FDA) has issued an approval letter for its antibiotic dalbavancin for the treatment of adult patients with complicated skin and skin structure infections.

The FDA has requested that Pfizer provides additional data for dalbavancin in line with new guidelines for studies showing non-inferiority as a basis for approval in antibacterial drugs.

Issues relating to deviations from current good manufacturing practices at a third-party manufacturer have also been highlighted in the approval letter.

The regulatory body has confirmed that the concerns do not specifically relate to dalbavancin but it is now working with the manufacturer to resolve outstanding issues.

Pfizer has also confirmed that it will work closely with the FDA to respond to the new guidance, specifically regarding the length of storage time following reconstitution of dalbavancin.

Dalbavancin is a once-weekly, two-dose glycopeptide antibiotic which the company regards as an important addition to its portfolio of antibacterial products and product candidates. It is indicated for use in skin infections including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

Earlier this month, Pfizer and Adolor announced a worldwide collaboration to develop and commercialise the compounds ADL5859 and ADL5747 for the treatment of pain.

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