Antares Pharma, Inc. (AIS, ATRS) Wednesday said 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 U.S. Food and Drug Administration.
Otrexup is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis.
The FDA has assigned a Prescription Drug User Fee Act date of October 14, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.
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