The US Food and Drug Administration (FDA) has accepted to review Antares Pharma's new drug application (NDA) of OTREXUP, designed for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
OTREXUP drug delivers methotrexate (MTX) using a proprietary parenteral drug delivery system Medi-Jet technology.
Medi-Jet enables patients to self-administer a drug subcutaneously or intramuscularly, while also enhancing safety with an integrated, shielded needle that protects against accidental needle stick and drug exposure, according to the company.
Antares Pharma president and chief executive officer Paul Wotton said the FDA's acceptance of the OTREXUP NDA is an important start to the review process and a significant milestone for the company's shareholders.
"We look forward to working closely with the FDA during their review of the application," Wotton added.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 14 October 2013, ten months from the official NDA filing.
