Medac Pharma announced that the FDA has accepted for review its New Drug Application (NDA) for its lead product candidate MPI-2505 (methotrexate). MPI-2505 is a subcutaneous injectable form of methotrexate (MTX) in a ready-to-use device indicated for rheumatoid arthritis (RA), poly-articular-course juvenile rheumatoid arthritis, and psoriasis.

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Administered via a ready-to-use injection device, MPI-2505 has been designed to improve bioavailability and overcome tolerability issues associated with some oral MTX therapies.

Medac Pharma expects to commercialize its subcutaneous MTX autopen device later this year upon FDA approval.

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