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# Genus Seeks Court Order Against Lannett’s Numbrino
- URL: https://www.fdaweb.com/genus-seeks-court-order-against-lannetts-numbrino/
- Published: 2020-12-03T12:00:00.000Z
- Updated: 2026-09-14T16:38:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148217

In a suit filed in a Maryland federal court, Genus Lifesciences says that Lannett Company made untrue statements to FDA in an NDA for its Numbrino, a cocaine-based anesthetic, and the agency has not performed its legal duty to withdraw approval of the NDA. The [suit](https://bloximages.chicago2.vip.townnews.com/trib.com/content/tncms/assets/v3/editorial/e/6d/e6de87b6-2911-551d-9208-c24a68474f63/5fbd29ca3f645.pdf.pdf?ref=fdaweb.com) acknowledges that Genus manufactures Goprelto, a competing cocaine-based anesthetic.

Genus alleges that after Lannett indicated to FDA that Numbrino would be manufactured in its facility in Cody, WY, the company closed the Cody facility and moved production to its Carmel, NY facility.

“Lannett’s Chemistry, Manufacturing, and Controls section \[of the NDA\] thus presented FDA with data about the wrong facility — one that was closed and where Lannett had no intention of manufacturing the drug — and failed to provide critical data about the facility where Lannett actually intended to manufacture Numbrino,” Genus says.

The company says it notified FDA of the untrue Lannett statements nine months ago and the agency “has refused to take the legally required action to initiate proceedings to withdraw Lannett’s approval. Federal law does not allow FDA to turn a blind eye to material, untrue statements in approved NDAs. Genus thus files this lawsuit to compel agency action unlawfully withheld and unreasonably delayed.”