PHILADELPHIA, 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.
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."
About Lannett Company, Inc. Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements, including, but not limited to, the FDA granting a hearing, a successful outcome of the hearing and future sales of the company's Methylphenidate ER products, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, including acquired products, and Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. These forward-looking statements represent the company's judgment as of the date of this news release. The company disclaims any intent or obligation to update these forward-looking statements.