Antares Pharma, Inc. 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.”