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October 18, 2012
08:33 EDTFLMLFlamel announces FDA acceptance of NDA for undisclosed hospital-based product
Flamel Technologies SA announced that the U.S. FDA has accepted the company's New Drug Application, or NDA, for an undisclosed hospital-based product. Flamel has received a Prescription Drug User Fee Act, or PDUFA, date, the target date for the FDA to complete its review of the NDA, of May 31, 2013. For competitive reasons, the Company has decided not to identify the product at this time, but intends to provide additional information at a later date. Flamel believes that the product could have a significant impact on the company's revenue generation and favorably impact its progression to profitability. If approved by the FDA, the product is expected to generate approximately $25M-$35M or more in peak annual revenues, subject to the company being able to market and price the product successfully, of which there can be no assurance.
News For FLML From The Last 14 Days
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July 30, 2015
07:56 EDTFLMLFlamel backs FY15 revenue guidance of $170M-$185M, consensus $194.87M
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07:56 EDTFLMLFlamel reports Q2 adjusted EPS 34c, consensus 40c
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July 22, 2015
08:31 EDTFLMLFlamel to begin U.S. public company reporting status in FY16
Flamel announced that as of June 30, it has determined that it no longer satisfies the definition of a "foreign private issuer" under the rules and regulations of the SEC. The company made the determination based on the fact that the proportion of its voting securities currently held by U.S residents is approximately 80% or greater and a majority of its executive officers are U.S. citizens or residents. As a result, beginning on January 1, 2016, the company will be filing Annual Reports on Form 10-K, commencing with the annual report to be filed for the year ended December 31, 2015, Current Reports on Form 8-K, Quarterly Reports on Form 10-Q as well as proxy statements with respect to meetings of shareholders, with the SEC as if it were a fully domestic U.S. company.

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