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February 27, 2013
07:33 EDTATRSAntares Pharma'a Otrexup NDA accepted by FDA
Antares Pharma announced that the New Drug Application for Otrexup, a potential new product for the subcutaneous delivery of methotrexate using Medi-Jet technology, has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. Otrexup is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and psoriasis. The FDA has assigned a target date of October 14, ten months from the official NDA filing, to complete its review of the NDA.
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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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