New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 5, 2013
07:04 EDTCOVNuvo Research announces FDA response to Pennsaid 2% NDA
Nuvo Research announced that its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien, has received a Complete Response Letter from the FDA following the review of Mallinckrodt's New Drug Application for diclofenac sodium topical solution, 2% w/w. In the letter, the FDA requires that Mallinckrodt successfully complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%.Similar pharmacokinetic studies submitted by Mallinckrodt with the NDA were not acceptable to the FDA because reserve samples were not retained at the clinical site. Mallinckrodt has indicated to Nuvo that it expects to complete the study and submit the results to the FDA in the third calendar quarter of 2013, and that it anticipates the FDA will provide a formal response to the filing within 6 months thereafter.
News For COV From The Last 14 Days
Check below for free stories on COV the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
April 15, 2014
09:23 EDTCOVBarclays medical supplies/devices analysts hold analyst/industry conference call
Subscribe for More Information
April 14, 2014
08:05 EDTCOVCovidien announces FDA 510(k) clearance for Kangaroo feeding tube
Subscribe for More Information
April 11, 2014
11:42 EDTCOVCovidien liability from recall appears limited, says Brean Capital
Subscribe for More Information
08:10 EDTCOVCovidien implements voluntary recall of devices
Subscribe for More Information
April 8, 2014
07:26 EDTCOVElsevier Business Intelligence to hold a conference
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