March 12, 2020 / 1:15 PM / 24 days ago

BRIEF-Acacia Pharma Announces Extension Of FDA Review Period For NDA For BYFAVO™

March 12 (Reuters) - ACACIA PHARMA GROUP PLC:

* REG-ACACIA PHARMA ANNOUNCES BRIEF EXTENSION OF FDA REVIEW PERIOD FOR NDA FOR BYFAVO™, AN ULTRA-SHORT ACTING AND REVERSIBLE ANESTHETIC FOR PROCEDURAL SEDATION

* ACACIA PHARMA IN-LICENSED US COMMERCIALIZATION RIGHTS TO BYFAVO FROM COSMO PHARMACEUTICALS N.V. IN JANUARY 2020

* US FOOD AND DRUG ADMINISTRATION (FDA) HAS EXTENDED REVIEW PERIOD FOR NEW DRUG APPLICATION (NDA) FOR BYFAVO™ (REMIMAZOLAM) BY UP TO 90 DAYS

* FDA HAS SET A NEW PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL OF REVIEWING AND ACTING ON NDA OF NO LATER THAN 5 JULY 2020 (PREVIOUS PDUFA TARGET DATE WAS 5 APRIL 2020) Source text for Eikon: Further company coverage: (Gdansk Newsroom)

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