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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.
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March 31, 2015
09:28 EDTATRSOn The Fly: Pre-market Movers
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07:03 EDTATRSAntares Pharma announces FDA approval of TEV-TROPIN
Antares Pharma announced that Ferring Pharmaceuticals has received FDA approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as Zomacton for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet. Ferring also received approval from the FDA to market the 10 mg needle-free injector device which, along with certain consumables, is supplied by Antares to Ferring. Ferring purchased the U.S. rights to Zomacton, formerly TEV-TROPIN, and to ZOMA-Jet, formerly Tjet, in December 2014 from Teva Pharmaceutical (TEVA). Ferring developed and has marketed Zomacton outside of the U.S. since 1988 and in 47 countries globally.
March 20, 2015
11:29 EDTATRSAntares Pharma management to meet with Oppenheimer
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