Anika Therapeutics announced Canada launch of CINGAL® viscosupplement, cleared to treat knee osteoarthritis pain. CINGAL will be marketed by Pendopharm.
Pendopharm is also Anika's sole commercialization partner for ORTHOVISC® and MONOVISC products in Canada.
Health Canada approved CINGAL in 4Q15 as a medical device. The 3rd-generation viscosupplement combines an FDA-cleared steroid with Anika's proprietary cross-linked sodium hyaluronate, yielding what is essentially MONOVISC® plus a steroid.
CINGAL obtained CE Mark approval in 1Q16 and is pending FDA approval in the U.S., where it has been assigned for premarket review by the Center for Drug Evaluation and Research.
Sources: Anika Therapeutics, Inc.; ORTHOWORLD