New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 10, 2014
07:03 EDTATRSAntares Pharma announces LEO Pharma's launch of OTREXUP to dermatologists
Antares Pharma announced LEO Pharma’s launch of OTREXUP to Dermatologists, the first U.S. Food and Drug Administration approved subcutaneous methotrexate product for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP is indicated for use in adults who need symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy. OTREXUP is also indicated for adults with severe active rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents, or children with active polyarticular juvenile idiopathic arthritis. OTREXUP was approved by the FDA in October 2013.
News For ATRS From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 26, 2015
07:02 EDTATRSAntares says FDA issues complete response letter for Sumatriptan Injection ANDA
Antares Pharma announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Abbreviated New Drug Application for Sumatriptan Injection USP for the acute treatment of migraine. The complete response letter from the FDA provided revisions to labelling and cited minor deficiencies. If approved, Sumatriptan Injection USP would represent the Company’s first ANDA approval and second device approved from the VIBEX auto injector platform. As previously disclosed, Teva Pharmaceutical Industries, Ltd. would distribute the product and share the profits equally with Antares Pharma. Eamonn P. Hobbs, President and CEO, stated, “We are pleased with the feedback received from the FDA in the complete response letter. The FDA has outlined the steps necessary to support approval of the ANDA, and we plan to work closely with the Agency on a response.”
06:16 EDTATRSAntares Pharma announces complete response letter for Sumatriptan ANDA
Subscribe for More Information
January 16, 2015
10:20 EDTATRSAntares Pharma management to meet with JMP Securities
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