Drugs

Genus Lifesciences Asks Court to Toss Lannett Drug Approval

Genus Lifesciences, which was awarded new chemical entity exclusivity (NCEE) by FDA for its Goprelto (cocaine hydrochloride), indicated for the induction of local anesthesia of the mucous membranes in certain diagnostic procedures and surgeries, is asking the DC federal court to declare FDA’s approval of Lannett’s Numbrino, a substantially similar cocaine hydrochloride drug, unlawful and to set aside its approval. At issue is the FDA interpretation of congressional requirements for an NCEE designation.

In its suit, Genus says that FDA accepted its Goprelto application on 11/23/16, approved it 12/14/17, and notified the company that it had been awarded NCEE 2/2018. The five-year NCEE extends to 12/14/22.

Genus argues that the congressional intent in establishing NCEE was to make it the broadest form of exclusivity by barring submission of a competitor’s application containing the same new chemical entity during the NCEE period unless the application contains a Paragraph 4 certification. Genus says FDA has attempted to narrow the scope of the NCEE by ruling that it bars submission of a competing application but not approval of a competing application that was submitted before NCEE was awarded.

In the instance at issue, Genus says, after the agency accepted the Genus application but before it was approved, the agency was in discussions with Lannett and failed to hold Lannett to the same intensive acceptance standard it applied to Genus. “FDA materially altered the standard and agreed to and did accept Lannett’s application without all of the dedicated scientific submissions that FDA had deemed essential for Genus,” the suit says.

According to the suit, FDA acknowledges that the two companies submitted substantially different information in their initial applications and contends that it has the discretion to hold Lannett to a different standard and that it could continue to review and approve Lannett’s application even after granting Genus NCEE.

Genus says FDA “lacks the discretion to manipulate the filing standard when doing so would thwart Congress’ statutory exclusivities.”

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