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# FDA ‘Misinterpreted’ Law in Goprelto Case, Court Says
- URL: https://www.fdaweb.com/fda-misinterpreted-law-in-goprelto-case-court-says/
- Published: 2020-09-16T12:00:00.000Z
- Updated: 2026-09-14T16:28:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147664

The DC federal court says FDA misinterpreted the Federal Food, Drug, and Cosmetic Act (FFDCA) when it approved Lannett’s Numbrino (cocaine HCl) nasal solution during the period of Genus Lifesciences’ five-year new chemical entity exclusivity for Goprelto (cocaine HCl) nasal solution. Genus filed suit after the agency approved Numbrino earlier this year, just three years after Genus was awarded five-year exclusivity.

Genus claimed the period of exclusivity bars all application approvals and submissions for competing drugs, including Lannett’s submission that occurred before Goprelto was approved.

FDA told the court that while Genus’ exclusivity period prohibits the agency from accepting any new competing drug applications, it does not bar it from approving applications that were already in the approval process.

The court said it agrees with FDA that the Genus exclusivity does not cover approvals, but disagrees with the agency’s reasoning. “The FFDCA prescribes timelines for approval of applications like Lannett’s based on the type of patent certification in the application,” the court said. “FDA admits that it disregarded these timelines. Since the court finds that FDA misinterpreted the FFDCA, the court’s inquiry stops here for now.”

The court acknowledged that there may be a loophole in the law covering new chemical entity exclusivity that doesn’t speak to a situation in which two companies submitted applications for a drug using cocaine that “has been known and used for various purposes as a drug for well over a century.”

But, the ruling says, “it is not the court’s loophole to close,” quoting an earlier decision that a court’s role is “to interpret the language of the statute enacted by Congress, not to improve upon it.”

The court denied summary judgment for FDA and Lannett and granted it in part to Genus.