Bioventus Receives FDA Premarket Approval for DUROLANE

By Julie A. Vetalice

Bioventus received FDA premarket approval for DUROLANE single-injection hyaluronic acid (HA) to treat pain associated with knee osteoarthritis (OA). U.S. launch is slated for early 2018.

DUROLANE is indicated to treat knee OA pain in patients that have not adequately responded to conservative therapy or simply analgesics. The product has been marketed ex-U.S. for over 15 years to treat pain associated with hip and knee OA, and it joins Bioventus' other products in the U.S.: HA GELSYN-3™ three-injection and and HA SUPARTZ FX™ five-injection regimens.

Source: Bioventus


Product Labels: Viscosupplement

Tags: Premarket Approval, Regulatory