Antares Pharma announced the submission of a New Drug Application (NDA) to the FDA for Otrexup for the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis. Otrexup is a combination product for the delivery of methotrexate using Medi-Jet technology, designed to enable patients to self-administer the drug subcutaneously or intramuscularly with an integrated, shielded needle that protects against accidental needle stick and drug exposure. Methotrexate is a disease-modifying anti-rheumatic drug (DMARD).
The NDA submission, subject to acceptance and approval by the FDA, was supported by data generated from a clinical development program completed in accordance with the FDA’s guidance and recommendations. Antares executed and completed all of the clinical studies agreed with the agency and described in the clinical development program.
For more information call (609) 359-3020 or visit www.antarespharma.com.