Antares Pharma announces FDA approval of OTREXUP

Antares Pharma announced the approval of OTREXUP injection by the Food and Drug Administration. OTREXUP is the first FDA approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, the company said. OTREXUP is indicated for adults with severe active rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents, or children with active polyarticular juvenile idiopathic arthritis. The FDA also approved adult use of OTREXUP for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy. The company said it expects the commercial launch of OTREXUP in early 2014.