Dalbavancin Delay: Pfizer Pulls NDA To Conduct Extra Phase III Trial
This article was originally published in The Pink Sheet Daily
Antibiotic study will take 18 months to complete, Pfizer says.
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With a Special Protocol Agreement and an experienced sales team lined up, all the firm has to do now is get hospitals excited about an expensive antibiotic in a highly-genericized market.
Durata has honor of having first drug approved under Qualified Infectious Disease Product designation and gains the benefits of an added five years of market exclusivity.
Full results for Durata’s dalbavancin and The Medicine’s Co.’s oritavancin – both lipoglycopeptides – suggest the mode of administration is likely to become a key differentiating factor if the drugs are approved.