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ZGNX > SEC Filings for ZGNX > Form 8-K on 10-Dec-2013All Recent SEC Filings

Show all filings for ZOGENIX, INC.

Form 8-K for ZOGENIX, INC.


10-Dec-2013

Other Events


Item 8.01. Other Events.

On December 10, 2013, Zogenix, Inc. ("Zogenix") announced that the U.S. Food and Drug Administration approved Zogenix's supplemental New Drug Application for a 4 mg dose of Sumavel DosePro (sumatriptan injection) Needle-free Delivery System. Sumavel DosePro is also approved in a 6 mg dose for the treatment of acute migraine and cluster headache.

Zogenix currently expects to launch the 4 mg dose of Sumavel DosePro in approximately June 2014.

***

Zogenix cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as "expects" and similar expressions are intended to identify forward-looking statements. These statements are based on Zogenix's current beliefs and expectations. These forward-looking statements include a statement regarding the timing of the launch of 4 mg dose of Sumavel DosePro. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the market potential for migraine treatments, and Zogenix's ability to compete within that market, including with the 4 mg dose of Sumavel DosePro; Zogenix's ability to successfully execute its sales and marketing strategy for the commercialization of Sumavel DosePro; unexpected adverse side effects relating to Sumavel DosePro that could result in recalls or product liability claims; Zogenix's reliance on Mallinckrodt to co-promote Sumavel DosePro; and other risks other risks described in Zogenix's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.


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