Table 1U.S. FDA-approved hyaluronan products and product information statements

ProductRegarding Treatment CourseRegarding Minimum # of InjectionsRegarding Other JointsRegarding Repeat Treatments
Hyalgan® (sodium hyaluronate); Fidia Pharmaceutical“A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals.”“The effectiveness of a single treatment cycle of less than 3 injections has not been established.”“The safety and effectiveness of the use of Hyalgan® in joints other than the knee have not been established.”“Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Hyalgan®. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle....”
Original PMA date: 5/28/97Hyalgan® is the only hyaluronan with demonstrated safety in a 30-month, repeat use, open-label trial in which 75 patients received a cycle of 5 weekly injections of Hyalgan® every 6 months.
MW: 0.5–0.73 million Da
Synvisc® (hylan G-F 20); Genzyme Corporation“Synvisc® is administered by intraarticular injection once a week (one week apart) for a total of three injections.”“The effectiveness of a single treatment cycle of less than three injections of Synvisc® has not been established.”“The safety and effectiveness of Synvisc® in locations other than the knee and for conditions other than osteoarthritis have not been established.”“The reactions seemed to occur more often when Synvisc® was injected into the knee as a repeat set of injections than when Synvisc® was injected as a first set of injections.”
Original PMA date: 8/08/97
MW: 6 million Da (hylan A)
Supartz® (sodium hyaluronate); Seikagaku Corporation“Supartz® is administered by intraarticular injection once a week (one week apart) for a total of 5 injections.”“The effectiveness of a single treatment cycle of less than 5 injections has not been established.”“The safety and effectiveness of the use of Supartz® in joints other than the knee have not been established.”“The safety and effectiveness of repeat treatment cycles of Supartz® have not been established.”
Original PMA date: 1/24/01
MW: 0.62–1.17 million Da
Orthovisc® (sodium hyaluronate), Anika Therapeutics, Inc.“Orthovisc® is injected into the knee joint in a series of intraarticular injections one week apart for a total of three or four injections.”The effectiveness of a single treatment cycle of less than 3 injections has not been established. Pain relief may not be seen until after the third injection.“The safety and effectiveness of the use of Orthovisc® in joints other than the knee have not been established.”“The effectiveness has not been established for more than one course of treatment.”
Original PMA date: 2/04/04
MW: 1–2.9 million Da
Euflexxa® (sodium hyaluronate), Ferring Pharmaceuticals“A dose of 2 ml is injected intraarticularly into the affected knee at weekly intervals for three weeks, for a total of three injections.”N/R“Safety and effectiveness of injection in conjunction with other intraarticular injectables, or into joints other than the knee has not been studied.”“The safety and effectiveness of repeated treatment cycles of EUFLEXXA™ have not been established.”
Original PMA date: (approved under the name Nuflexxa)
MW: 2.4–3.6 million Da

Da: Daltons; MW: molecular weight; PMA: premarket approval

From: 1, Introduction

Cover of Treatment of Primary and Secondary Osteoarthritis of the Knee
Treatment of Primary and Secondary Osteoarthritis of the Knee.
Evidence Reports/Technology Assessments, No. 157.
Samson DJ, Grant MD, Ratko TA, et al.

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