Novartis, FDA Battle Over Generic Drug Labeling in DC Circuit

A three-judge panel wrestled Thursday with Novartis AG’s challenge against the FDA over its approval of a generic version of its heart failure drug, pressing both the manufacturer and agency on the accuracy of the drug labels.

The US Court of Appeals for the District of Columbia Circuit tried to drill down into Novartis’s reasoning for opposing the Food and Drug Administration’s approval of MSN Laboratories’ generic Entresto.

Novartis challenged the FDA last year alleging the agency unlawfully approved copies of its drug because the generic version lacked critical safety information on its labeling. A federal judge rejected in ...