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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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