Novartis Urges Court to Break FDA Logjam Over MSN Entresto Copy

The FDA told Novartis AG it won’t act on a judgment delaying approval of MSN Laboratories Pvt. Ltd.’s copy of its blockbuster heart-failure drug until the court rules on MSN’s request to pause enforcement of that judgment.

The US Food and Drug Administration’s position was detailed in a letter Novartis submitted Wednesday to the US District Court for the District of Delaware. The agency’s decision effectively preserves MSN’s launch opportunity before the court rules on Novartis’ stay request, the company told judge Richard G. Andrews.

The Swiss drugmaker is urging the judge to address three pending MSN motions during a ...