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Subsys

Generic name: fentanyl
Treatment for: Pain

Update: Subsys (fentanyl sublingual spray) Now FDA Approved - January 4, 2012

INSYS Announces NDA PDUFA Date for Fentanyl SL Spray

PHOENIX--(BUSINESS WIRE)--May 20, 2011 - INSYS Therapeutics, Inc. (formerly NeoPharm, Inc.) today announced that the U.S. Food and Drug Administration (FDA) has provided an anticipated Prescription Drug User Fee Act (PDUFA) goal date of January 4, 2012 for its review of the New Drug Application (NDA) for Fentanyl SL Spray.

"We look forward to working with the FDA during the review process and, if approved, making this proprietary product available for patients who suffer from breakthrough cancer pain," said Larry Dillaha, M.D., INSYS Chief Medical Officer.

About Insys Therapeutics, Inc.

Insys Therapeutics, Inc., based in Phoenix, Arizona, is developing and seeking to commercialize innovative pharmaceutical products that target the unmet needs of cancer patients, with an initial focus on cancer-supportive care. Insys utilizes proprietary technologies to develop product candidates that address the clinical shortcomings of existing commercial products. Additional information can be obtained by visiting the Insys Therapeutics web site at www.insysrx.com.

Forward Looking Statements

This press release contains "forward-looking statements" that may be identified by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," “look forward to” and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, statements relating to the FDA's review of the Fentanyl SL Spray NDA, the status of Insys' drug development programs, the prospects, potential regulatory approval and potential commercialization of Fentanyl SL Spray, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to Insys' ability to obtain financing to fund its operations, difficulties or delays in the development, receipt of regulatory approval, production, and marketing of Insys' product candidates, Insys' ability to hire, train and successfully deploy a sales force, unexpected adverse side effects or inadequate therapeutic efficacy of Insys' product candidates, and the uncertainty of patent protection for Insys' intellectual property or trade secrets. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned in this press release. For the foregoing reasons, you should not rely on these forward-looking statements as a prediction of actual future results.

Contact: Insys Therapeutics, Inc.
Michael L. Babich
602-910-2617
mbabich@insysrx.com

Posted: May 2011

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