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Avadel Pharmaceuticals plc (AVDL), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the Company’s fourth Hospital Product, AV001. It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 15, 2019.
“If approved, AV001 will be our fourth revenue producing Hospital Product,” said Greg Divis, interim Chief Executive Officer of Avadel. “We are pleased that the FDA has granted AV001 an accelerated 6-month Priority Review. Subsequent to our NDA submission, the FDA granted an NDA approval for a parenteral product with the same Active Pharmaceutical Ingredient (API) as AV001. We will continue to monitor the marketplace as we work with FDA on our application and prepare for a successful launch of AV001.”
AVADEL PHARMACEUTICALS PLC ADR
Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. It offers Bloxiverz, Vazculep, and Akovaz. The company was founded on December 1, 2015 and is headquartered in Dublin, Ireland
Avadel Pharmaceuticals plc (AVDL), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the Company’s fourth Hospital Product, AV001. It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 15, 2019.
“If approved, AV001 will be our fourth revenue producing Hospital Product,” said Greg Divis, interim Chief Executive Officer of Avadel. “We are pleased that the FDA has granted AV001 an accelerated 6-month Priority Review. Subsequent to our NDA submission, the FDA granted an NDA approval for a parenteral product with the same Active Pharmaceutical Ingredient (API) as AV001. We will continue to monitor the marketplace as we work with FDA on our application and prepare for a successful launch of AV001.”
AVADEL PHARMACEUTICALS PLC ADR
Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. It offers Bloxiverz, Vazculep, and Akovaz. The company was founded on December 1, 2015 and is headquartered in Dublin, Ireland
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