Cumberland Pharmaceuticals, a speciality pharma firm based in Nashville, has secured FDA approval for its new line of methotrexate products to treat rheumatoid arthritis (RA).
The approval of RediTrex, which is also approved for psoriasis, followed several communications with the FDA and several amendments to the New Drug Application the company submitted to the FDA in late 2018.
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.
Cumberland said it 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.