The Food and Drug Administration (FDA) has approved RediTrex (methotrexate injection; Cumberland) for the management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy. It is also indicated for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

The product will be supplied in preservative-free, single-dose prefilled syringes delivering methotrexate in the following dosage strengths: 7.5mg, 10mg, 12.5mg, 15mg, 17.5mg, 20mg, 22.5mg and 25mg. 

RediTrex is administered as a once-weekly subcutaneous injection; for patients who require alternative dosing (doses <7.5mg per week or doses >25mg per week; high-dose regimens, or dose adjustments of <2.5mg increments), another formulation of methotrexate should be used.

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“We are delighted by the FDA approval of RediTrex for the United States,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “We are looking forward to bringing this important product to the patients seeking an easy-to-use methotrexate injectable.”

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