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Anika's CINGAL Premarket Review to Proceed through FDA Center for Drug Evaluation and Research -

FDA has assigned Anika Therapeutics' CINGAL® to the Center for Drug Evaluation and Research for its premarket review.

CINGAL is the first combination viscosupplement formulated with Anika’s cross-linked sodium hyaluronate (currently marketed as single-injection MONOVISC®) and an FDA-approved steroid to treat inflammation.
 
Earlier this year, Anika announced positive results from its CINGAL 13-01 and 13-02 studies, demonstrating the efficacy and safety of a single injection of CINGAL for treatment of pain caused by knee osteoarthritis (OA), as well as the safety of a repeat injection.

CINGAL was approved in Canada as a medical device to treat pain associated with knee OA, and is under review in the EU.

Source: Anika Therapeutics, Inc.

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