GREENBELT, Md. (Legal Newsline) – A Pennsylvania pharmaceutical company has sued the U.S. Food and Drug Administration for an alleged failure to act on its complaints about a competitor.
Genus Lifesciences filed sued Nov. 12 in Maryland federal court regarding an application by Lannett Company to sell an anesthetic known as Numbrino that contains cocaine.
Genus says there was an untrue statement in the application, which would require the FDA to withdraw its approval.
Genus complains Lannett said Numbrino would be produced in Wyoming but shuttered that facility while the application was pending. The company moved production to New York.
“Lannett’s CMC section 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,” the suit says.
Nine months after Genus submitted its complaint, the FDA has not acted, the suit says.