Antares Pharma, Inc. ATRS today announced that the New Drug
Application (NDA) for OTREXUP™, a potential new product for the subcutaneous
delivery of methotrexate (MTX) using Medi-Jet™ technology, has been accepted
by the U.S. Food and Drug Administration (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 (RA), poly-articular-course juvenile RA and psoriasis.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October
14, 2013, ten months from the official NDA filing. The PDUFA date is the
target date for the FDA to complete its review of the NDA.
“The FDA's acceptance of the OTREXUP NDA is an important start to the review
process and a significant milestone for our shareholders,” said Paul K. Wotton
Ph.D., President and Chief Executive Officer. “We look forward to working
closely with the FDA during their review of the application.”
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