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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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