BioCentury
ARTICLE | Clinical News

Dalvance dalbavancin regulatory update

August 11, 2014 7:00 AM UTC

In the rule, CMS said it does not believe Dalvance “meets the substantial clinical improvement criterion” to qualify for NTAP. The agency noted that the trials that served as the basis for approval for were non-inferiority trials. On a conference call to discuss 2Q14 earnings, Durata acknowledged that the NTAP denial will likely reduce the inpatient use of the drug, but said an NTAP was a “long shot” and that it is promoting the drug for out-patient care. ...