BAXFENDY

AstraZeneca AB added U.S. Patent 9,353,081 to the Orange Book for BAXFENDY (baxdrostat), NDA 219878.

AstraZeneca AB listed U.S. Patent 9,353,081 for BAXFENDY (baxdrostat) in the Orange Book for NDA 219878.

AstraZeneca AB's baxdrostat (BAXFENDY) received FDA approval for NDA 219878, establishing a new product entry in the Orange Book database.

AstraZeneca's baxdrostat (Baxfendy) received FDA approval for a new indication under supplemental application 219878-002.

AstraZeneca AB received New Chemical Entity exclusivity for Baxfendy (baxdrostat) upon FDA approval of NDA 219878, providing five years of regulatory exclusivity from the approval date.