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December 17, 2012
09:02 EDTATRSAntares Pharma submits NDA for OTREXUP to FDA
Antares Pharma announced the submission of a NDA to the FDA for OTREXUP, a combination product for the delivery of methotrexate using Medi-Jet technology. OTREXUP was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and moderate to severe psoriasis. The NDA submission, subject to acceptance and approval by the FDA, was supported by data generated from a clinical development program completed in accordance with the FDAs guidance and recommendations. Antares executed and completed all of the clinical studies agreed with the agency and described in the clinical development program.
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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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