Lannett Provides Further Update On Methylphenidate ER Tablets

PHILADELPHIA, Feb. 22, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it was notified by U.S. Food and Drug Administration (FDA) late yesterday afternoon that FDA suspended indefinitely the deadline for the Company to submit materials in support of its request for a hearing to consider FDA's proposal that Lannett withdraw its Abbreviated New Drug Application (ANDA) for Methylphenidate ER.

"We appreciate the FDA acknowledging our request to provide certain documents related to Methylphenidate ER and providing additional time for review," said Arthur Bedrosian, chief executive officer of Lannett. "At the appropriate time, we intend to submit documentation in an effort to convince the FDA that our Methylphenidate ER products are bioequivalent to the brand version (Concerta®) and should remain on the market."

Since the documents requested by Lannett may take an undetermined amount of time to retrieve, review and redact, FDA agreed to delay the submission deadline. Once the documents are released, FDA is expected to discuss their sufficiency with Lannett and establish new dates for submission of materials in support of the hearing request. 

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.

Contact:      

Robert Jaffe


Robert Jaffe Co., LLC


(424) 288-4098


rjaffe@rjaffeco.com

 

SOURCE Lannett Company, Inc.


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