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TSPT > SEC Filings for TSPT > Form 8-K on 26-Dec-2012All Recent SEC Filings

Show all filings for TRANSCEPT PHARMACEUTICALS INC | Request a Trial to NEW EDGAR Online Pro

Form 8-K for TRANSCEPT PHARMACEUTICALS INC


26-Dec-2012

Other Events


Item 8.01 Other Events.

As previously reported, on July 19, 2012, Transcept Pharmaceuticals, Inc. ("Transcept") received a Paragraph IV notice letter from Watson Laboratories, Inc. - Florida ("Watson"), advising Transcept that Watson had filed an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") for generic versions of Intermezzo® (zolpidem tartrate) sublingual tablet C-IV. In response to Watson's ANDA, on August 27, 2012, Transcept joined Purdue Pharma and Purdue Pharma L.P. (collectively, "Purdue") in filing an action (the "Action") against Watson, Watson Pharmaceuticals, Inc. and Watson Pharma, Inc.

On November 28, 2012, Watson withdrew its ANDA, and, as a result of such withdrawal, on December 18, 2012 Transcept and Purdue agreed to voluntarily dismiss the Action without prejudice and on December 20, 2012 a court order was entered to such effect. The dismissal of the Action has no effect on the ANDA filed by Actavis Elizabeth LLC, a wholly owned subsidiary of Watson Pharmaceuticals, Inc., which was reported by Transcept on July 19, 2012.

For information on the risks associated with Transcept's efforts to secure and maintain intellectual property protection for Intermezzo, please see the Risk Factors section of Transcept's Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 13, 2012. The information contained herein is intended to be considered in the context of more complete information included in Transcept's filings with the SEC and other public announcements that Transcept has made or may make from time to time by press release or otherwise.


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