Antares Pharma, Inc. (ATRS) Monday announced that it has submitted a New Drug Application, or NDA to the U.S. Food and Drug Administration, or the FDA for OTREXUP, a combination product for the delivery of methotrexate (MTX) using Medi-Jet technology.
The company focusing on self-administered parenteral pharmaceutical products stated that OTREXUP was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis.
"The NDA submission of OTREXUP represents yet another significant accomplishment in the Company's history," said Paul K. Wotton Ph.D., President and Chief Executive Officer. "It is the first product designed for convenient subcutaneous delivery of methotrexate in patients with rheumatoid arthritis or psoriasis. We believe OTREXUP will benefit most patients that have not reached a satisfactory response to oral methotrexate alone or in combination with a biologic or another disease-modifying anti-rheumatic drug."
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