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Stock Market & Financial Investment News

News Breaks
May 6, 2014
08:33 EDTATRSAntares Pharma announcse update to QuickShot testosterone program
Antares Pharma announced that a meeting was held with the U.S. Food and Drug Administration to discuss a registration study for the VIBEX QuickShot auto injector in testosterone deficient adult males. The study will include approximately 150 adult males with testosterone blood levels less than 300 ng/dL, and will begin recruitment in the third quarter of 2014. The study is designed to show that once-weekly self-administration of testosterone with the VIBEX QuickShot auto injector can safely achieve normal blood levels of testosterone in hypogonadal men.
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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