Cumberland gets FDA nod for RediTrex

Specialty pharmaceutical company Cumberland Pharmaceuticals has received the Food and Drug Administration’s blessing 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.

Methotrexate is approved in the United States as both an oral and injectable treatment. While oral formulations are widely available, injectable methotrexate has been shown to result in increased efficacy, greater continuation rates and less discomfort for patients. Cumberland's methotrexate products will provide enhancements and patient benefits over conventional injectable methotrexate products currently available in the United States, the company said.

Cumberland has acquired exclusive U.S. commercial rights to Nordic’s injectable methotrexate line of products. Nordic is a privately-owned European pharmaceutical company with a presence in 17 countries.

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

Cumberland will launch two injectable methotrexate product lines, with both product offerings intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriasis.