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News Breaks
April 16, 2014
10:27 EDTENDPEndo International says AMS unit received FDA warning letter
In a regulatory filing, Endo International disclosed that as previously reported in Endo Health Solutions's Form 10-K filed with the SEC on March 3, in February 2014, the United States FDA conducted an inspection of the Minnetonka, Minnesota facility of American Medical Systems, AMS, a subsidiary of Endo International. Following such inspection, the FDA issued three observations on a Form 483 Notice of Inspectional Observations dated February 24. These observations, previously self-identified by AMS, were being addressed through a corrective action plan which AMS originally expected to complete beyond 2015. On April 14, AMS received a Warning Letter from the FDA, dated April 10. The Warning Letter relates to the same matters as identified in the Form 483 Notice. Specifically, the Warning Letter discusses observations related to process validation, risk analysis and corrective and preventive action procedures. The letter states that the corrective actions which AMS reviewed with the FDA on March 20, 2014 appear to be adequate, but it goes on to state that many of the actions have not yet been completed and will need to be validated in a follow-up inspection. AMS has 15 days to respond to the Warning Letter. AMS expects only limited related impact to its business at this time. The Minnetonka, Minnesota facility will continue to manufacture and ship products while AMS works with the FDA.
News For ENDP From The Last 14 Days
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January 22, 2015
14:03 EDTENDPAuxilium to host special shareholder meeting
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January 21, 2015
18:27 EDTENDPOn The Fly: After Hours Movers
UP AFTER EARNINGS: eBay (EBAY), up 2.9%... United Rentals (URI), up 1.5%. ALSO HIGHER: Minerva (NERV), up 16.1% after reporting positive Phase 1 data with MIN-202... Endo (ENDP), up 3.1% after it was announced that Endo will replace Covidien in S&P 500 as of 1/26 close... Covidien (COV) is up 1%. DOWN AFTER EARNINGS: F5 Networks (FFIV), down 15.8%... Xilinx (XLNX), down 6.1%... Discover Financial Services (DFS), down 3.3%... American Express (AXP), down 2.2%. ALSO LOWER: BioMarin (BMRN), down 2.5% after filing to sell 7.25M shares of common stock... Kinder Morgan (KMI), down 1.9% after announcing that it will acquire Hiland Partners for approximately $3B and reporting fourth quarter results... Cisco (CSCO), down 1.4% after Bloomberg reported that Oracle's (ORCL) Ellison said that Oracle's new Virtual Compute Appliance is cheaper than Cisco's product.
18:06 EDTENDPS&P announces changes to the S&P 500, MidCap 400, SmallCap 600 indices
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17:19 EDTENDPBoston Beer to replace Endo in S&P 400 as of 1/26 close
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17:18 EDTENDPEndo to replace Covidien in S&P 500 as of 1/26 close
January 20, 2015
07:00 EDTENDPEndo price target raised to $98 from $86 at Piper Jaffray
Piper Jaffray raised its price target for Endo shares to $98 saying Xiaflex's market expansion opportunities are not fully appreciated by the broader market. It keeps an Overweight rating on the stock.

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