Pharma Times, the manufacturer of Otrexup (methotrexate injection) has announced the United States Food and Drug Administration (USFDA) approval of Otrexup. Otrexup is the first approved subcutaneous methotrexate injection for once-weekly use. The drug can be self-administered with a single-dose, easy-to-use, disposable auto-injector device. Otrexup is indicated for the treatment and management of severe active rheumatoid arthritis (RA) in patients who are either intolerant or unresponsive to first-line therapies such as full dose, non-steroidal anti-inflammatory agent (NSAIDs). Otrexup is also indicated for juveniles with active polyarticular juvenile idiopathic arthritis (p.I1A). Otrexup is also indicated for the symptomatic management of severe recalcitrant psoriatic problems that are not adequately controlled by other treatments. Methotrexate treatment is generally initiated with oral formulations. However, symptoms may not be adequately controlled in several patients either due to tolerance or inefficacy. The company is pleased to receive the USFDA approval for Otrexup, and it is an important milestone in the treatment of RA, NIA, and psoriasis, said Dr.Paul Wotton, President & CEO, Antares Pharma Inc. The regulatory approval of Otrexup reflected the strategic milestone and potentially validated the c. s proprietary VIBEX Medi-Jet technology.