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FDA accepts Allergan's sNDA for single-dose administration of DALVANCE

Oct. 09, 2015 8:04 AM ETAllergan plc (AGN) StockAGNBy: Douglas W. House, SA News Editor
  • The FDA accepts for filing Allergan's (NYSE:AGN) supplemental New Drug Application (sNDA) for single-dose administration (1500 mg) of DALVANCE (dalbavancin) for the treatment of adults with acute bacterial skin and skin structure infections ((ABSSSI)) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
  • DALVANCE, originally cleared by the FDA in May 2014, is currently administered in a two-dose regimen of 1000 mg followed by 500 mg one week later.

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