Cumberland pharmaceuticals inc. receives fda approval for reditrex™ product line

Cumberland pharmaceuticals inc. announced that it has received approval from the u.s. food and drug administration (fda) 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 of the product came after a number of communications with the fda and several amendments to the new drug application submitted to the fda in late 2018. methotrexate is approved in the u.s. 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 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. the injectable u.s. methotrexate market totaled over 670,000 prescriptions last year, with approximately $80 million in overall sales. this methotrexate market has grown at a rate of 72% over the previous three years. cumberland's goal is to achieve a significant share of the injectable methotrexate market over time through the introduction of reditrex.
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