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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval