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Anika Therapeutics (ANIK) Monovisc PMA Appeal Not Approved by FDA

December 4, 2012 5:10 PM EST Send to a Friend
Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today that it has received correspondence from the Chief Scientific Officer of the Center for Devices and Radiological Health of the U.S. FDA upholding the non-approvable decision for the Monovisc PMA that was previously disclosed. The company had utilized the FDA’s appeal process to continue to discuss the Monovisc PMA with the FDA.

The company plans to schedule a meeting with the FDA as soon as possible to determine the next steps concerning the Monovisc product.




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