Lannett (LCI) Receives FDA Extension on Methylphenidate Hydrochloride ER Tabs Document Submission
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Lannett Provides Update On Methylphenidate ER Tablets
November 30, 2016 6:56 AM ESTPHILADELPHIA, Nov. 30, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today 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.Â
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... More