“The Court further finds that FDA did not act arbitrarily by excluding part of Entresto’s dosing regimen from MSN’s generic drug label,” U.S. District Judge Dabney L. Friedrich wrote in her memorandum opinion unsealed with minimal redactions. “For these reasons, the Court will uphold FDA’s approval of MSN’s generic drug.”
October 17, 2024 at 10:23 AM
3 minute read
A District of Columbia federal judge has upheld the Food and Drug Administration’s approval of a generic heart failure medication without deferring to the agency’s interpretation of the Food, Drug and Cosmetic Act.
U.S. District Judge Dabney L. Friedrich, bound by the U.S. Supreme Court’s Loper Bright decision overturning “Chevron deference,” has rejected Hogan Lovells’ arguments accusing the FDA of unlawfully approving generic Entresto.
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Judge Dabney Friedrich of the U.S. District Court for the District of Columbia. Photo: Diego M. Radzinschi/ALM
