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May 20, 2014
07:02 EDTATRSAntares Pharma announces publication of three abstracts
Antares Pharma announced the publication of three abstracts at this year’s European League against Rheumatism Annual Congress being held in Paris, France on June 11 through June 14.In partnership with clinical researchers in the United States and Europe, Antares Pharma, the maker of OTREXUP for subcutaneous injection, supports original research intended to better understand the clinical role of subcutaneous methotrexate in the treatment of rheumatoid arthritis. Researchers from Switzerland, the United Kingdom, and the United States Veterans Administration will present original research at EULAR supported by unrestricted grants from Antares Pharma.
News For ATRS From The Last 14 Days
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January 30, 2015
10:14 EDTATRSAntares Pharma management to meet with Oppenheimer
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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
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