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FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant

Ocular Therapeutix - updated logoOcular Therapeutix (NSDQ:OCUL) said today that the FDA formally accepted its resubmitted new drug application for Dextenza, an ocular implant designed to administer pain-relief drugs following ophthalmic surgery.

The FDA issued a complete response letter to the Bedford, Mass.-based company last year, rejecting Ocular’s Dextenza application for the second time. The U.S. regulatory agency is set to decide whether or not to approve Dextenza based on its revised application by Dec. 28.

Get the full story at our sister site, Drug Delivery Business News.

The post FDA to review Ocular Therapeutix’s resubmitted NDA for Dextenza implant appeared first on MassDevice.

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