New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

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
Sign up for a free trial to see the rest of the stories you've been missing.
December 19, 2014
09:11 EDTENDPEndo price target raised to $90 from $77 at Sterne Agee
Subscribe for More Information
December 16, 2014
08:58 EDTENDPEndo a top pick for 2015, says Sterne Agee
Subscribe for More Information
December 11, 2014
17:04 EDTENDPEndo registration statement relating to Auxilium declared effective by SEC
Subscribe for More Information
December 9, 2014
07:08 EDTENDPEndo completes acquisition of rights to Natesto from Trimel BioPharma
Endo International announced the completion of the acquisition of rights to Natesto, a testosterone nasal gel, the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma, a wholly-owned subsidiary of Trimel Pharmaceuticals for $25M including additional payments upon the achievement of certain regulatory and sales milestones. Endo will collaborate with Trimel on all regulatory and clinical development activities regarding Natesto. Endo intends to launch the product, through its Endo Pharmaceuticals subsidiary, in the Q1 of 2015.
December 8, 2014
09:32 EDTENDPSyneron Medical signs agreement with AMS to supply holmium laser for urology
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use