According to the company, Rasuvo will be available in ten dosage strengths, ranging from 7.5mg to 30mg in 2.5mg increments and will be launched in the US.
The company concurrently announced that the US District Court for the District of Delaware has denied a motion for a preliminary injunction filed by Antares Pharma.
Medac Pharma president and CEO Terri Shoemaker said the company is happy to have secured approval for its lead product, Rasuvo.
"Methotrexate has long been recognized as a mainstay in rheumatoid arthritis therapy. With its virtually painless administration, broad dose range, and significantly enhanced bioavailability, we believe Rasuvo may benefit those patients using methotrexate," Shoemaker said.
"We’re pleased with the Court’s decision and are moving forward with our commercialization efforts as planned."
MTX remains the most commonly used drug for treating RA and is recommended by both the American College of Rheumatology and European League Against Rheumatism as a first-line therapy for RA patients.