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# Genus Petition Against Lannett Cocaine NDA
- URL: https://www.fdaweb.com/genus-petition-against-lannett-cocaine-nda/
- Published: 2019-08-19T12:00:00.000Z
- Updated: 2026-09-15T01:44:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144796

Genus Lifesciences has petitioned FDA seeking its rescission of a Lannett 505(b)(2) NDA for a cocaine hydrochloride product. Genus 12/2017 gained approval for Goprelto (cocaine hydrochloride) nasal solution, indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.

The Genus [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-3855-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) argues that FDA is applying two different review standards for the competing products because the agency required five separate studies for the Genus submission that Lannett is allegedly not required to perform. It asks that FDA rescind the acceptance of the Lannett submission if it was not required to conduct QT prolongation, renal, hepatic, leachable, or “other studies deemed necessary for an NDA for a cocaine hydrochloride product to be sufficiently complete to permit substantive review.” It also asks that the agency refuse to file any reapplication by Lannett until the expiration of the new chemical entity exclusivity attached to Genus’ NDA.