FDA approves Monovisc for Osteoarthritis of the Knee - Anika/DuPuy

Anika Therapeutics, Inc. announced it has received marketing approval for Monovisc from the FDA. Monovisc is a single injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients suffering from Osteoarthritis (OA) of the Knee.

Monovisc is the first FDA approved single injection product with HA from a non-animal source. It is comprised of a sterile, clear, biocompatible, resorbable, viscoelastic fluid composed of partially cross-linked sodium hyaluronate (NaHA) in phosphate buffered saline.

Monovisc will be marketed in the U.S. by DePuy Synthes, Mitek Sports Medicine (Mitek), a leading orthopaedic sports medicine company. The product is currently sold in a variety of territories, including Canada, the U.K. and several countries in the Middle East, Europe and Asia. Commercial introduction for Monovisc in the U.S. is planned to take place in conjunction with the annual meeting of the American Academy of Orthopedic Surgeons to be held in New Orleans, March 11 to 15, 2014.