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.
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion