Pharmaceutical company Cumberland Pharmaceuticals Inc (NASDAQ:CPIX) revealed on Monday the receipt of approval from the US Food and Drug Administration (FDA) for RediTrex for treating adult and paediatric patients with rheumatoid arthritis, as well as adults with psoriasis.
The company said the approval of its new line of methotrexate products RediTrex (methotrexate) injection follows a number of communications with the US FDA, as well as several amendments to the New Drug Application submitted to the FDA in late 2018.
According to the company, methotrexate is approved in the US 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.
In conjunction, Cumberland has acquired exclusive US commercial rights to Nordic Group BV's injectable methotrexate line of products. Cumberland will launch two injectable methotrexate product lines within the US, with both product offerings intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriasis.
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