Lannett: FDA To Withdraw Approval Of ANDA For Methylphenidate ER Tablets

(RTTNews) - Lannett Company, Inc. (LCI) announced it has received a notice from the U.S. FDA that it will seek to withdraw approval of the company's ANDA for Methylphenidate Hydrochloride Extended-Release Tablets. Lannett has until November 17, 2016 to request the hearing and until December 19, 2016 to submit all data, information and analyses.

Arthur Bedrosian, CEO of Lannett, said: "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."