Ad comm review today for Durata and Cubist


The Anti-Infective Drugs Advisory Committee reviews Durata Therapeutics' (DRTX) dalbavancin and Cubist Pharmaceuticals' (CBST) tedizolid today.

The FDA granted both products priority review status under the less-rigorous "non-inferiority" method.

Dalbavancin is comparable to vancomycin, but it is administered via two IV infusions a week apart and enables the patient to avoid two weeks of hospitalization.

Tedizolid is also comparable to an existing drug but it will be evaluated for hospital-acquired MRSA infections.

Two other antibiotics given the accelerated review have a heightened risk of serious adverse events and/or death.

(JNJ) (PFE)

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    both halted?
    31 Mar 2014, 07:40 AM Reply Like
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