Cumberland receives FDA approval for RediTrex product line
Cumberland announced that it has received approval from the U.S. FDA for RediTrex, its new line of methotrexate products. RediTrex 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 we submitted to the FDA in late 2018. Cumberland has acquired exclusive U.S. commercial rights to Nordic Group B.V.'s injectable methotrexate line of products. Nordic is a privately-owned European pharmaceutical company with a presence in 17 countries. The company focuses on the development and commercialization of niche hospital and orphan products, aiming to address unmet medical needs. Nordic's methotrexate products are established market leaders in multiple European countries. 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.