FDA Advisers Recommend Approval of Two Antibiotics

By Kelly Young

A panel of advisers to the FDA has voted unanimously to recommend approval of two drugs to treat serious Gram-positive acute bacterial skin infections, including methicillin-resistant Staphylococcus aureus, Reuters reports.

Tedizolid (to be marketed as Sivextro) is intended to be used once a day as an intravenous or oral treatment. This drug can be given less often and for shorter time periods and could have fewer side effects than linezolid (Zyvox), one of the current options.

Dalbavancin (to be marketed as Dalvance) would be given on days 1 and 8. Advisers expressed concern about patients receiving the second dose. They also recommended that the manufacturer conduct post-marketing safety studies on dalbavancin's potential to cause liver problems.