Lannett faces closing window to request FDA approval withdrawal hearing

In the aftermath of the Food and Drug Administration’s proposal to withdraw its approval of Lannett’s methylphenidate hydrochloride extended-release tablet — which led to its stock falling 12.9% last week — the company has responded to the regulatory notice. 

 

“We intend to review the scientific rationale for FDA's most recent position and compile the scientific evidence to convince FDA's Office of Generic Products that our product should continue to be marketed,” the company’s CEO Arthur Bedrosian said. 

 

The FDA’s proposal to withdraw approval allows the company to request a hearing, though it only has until Nov. 17 to do so, and it must submit all data, information and analyses that the request relies on by Dec. 19.