Lannett (LCI) Receives FDA Extension on Methylphenidate Hydrochloride ER Tabs Document Submission

November 30, 2016 6:56 AM EST

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Lannett Company, Inc. (NYSE: LCI) announced that the U.S. Food and Drug Administration (FDA) granted the company a 90-day extension to submit documentation concerning its Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. The new deadline for submitting the supporting documentation is March 20, 2017.

It is hoped that the extension will allow the Agency sufficient time to provide the underlying documents on which its decision was based. Lannett filed a request under the Freedom of Information Act for those supporting documents. Based on the additional information Lannett will provide, FDA will decide whether to grant a hearing to evaluate the issue further. As announced on October 19, 2016, the Company received a notice from the FDA that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate HCl ER Tablets. That decision is reportedly based on a revised Agency methodology for evaluating bioequivalence of extended release formulations of the drug.

"We submitted our request for the hearing and began preparing our supporting documentation," said Arthur Bedrosian, chief executive officer of Lannett. "We remain confident that our Methylphenidate ER products are safe and effective. They should continue to be marketed to preserve patient and prescriber choice, and to maintain an affordable alternative drug on the market."



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