Lannett (LCI) Receives FDA Notice of Intention to Withdraw Methylphenidate HCl ER Tablets ANDA; Offers Commentary
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Lannett Comments On FDA Proposal Regarding Methylphenidate Extended Release Tablets
October 19, 2016 6:57 AM EDTPHILADELPHIA, Oct. 19, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. FDA's proposal includes an opportunity for Lannett to request a hearing on this matter.Â
"We remain confident that our Methylphenidate ER products are safe and effective," said Arthur Bedrosian, chief executive officer of Lannett.... More
