Cumberland Pharmaceuticals Receives FDA Approval for RediTrex

Feb 25, 2020 at 12:09 pm by Staff


At the end of 2019, Nashville-based Cumberland Pharmaceuticals announced approval from the U.S. Food and Drug Administration for RediTrex™, its new line of methotrexate products.

RediTrex (methotrexate) injection is designed for the treatment of adult and pediatric patients with rheumatoid arthritis, as well as adults with psoriasis. The approval came after a number of communications with the FDA and several amendments to the New Drug Application Cumberland submitted to the FDA in late 2018.

While oral formulations of methotrexate are widely available, injectable methotrexate has been shown to result in increased efficacy, greater continuation rates and less discomfort for patients. According to company officials, Cumberland's methotrexate products will provide enhancements and patient benefits over conventional injectable methotrexate products currently available in the U.S. Cumberland will launch two injectable methotrexate product lines within the U.S., with both product offerings intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriasis.

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