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BRIEF-Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA
July 11, 2017 / 9:18 PM / 5 months ago

BRIEF-Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA

July 11 (Reuters) - Ocular Therapeutix Inc

* Ocular Therapeutix™ receives complete response letter from fda for dextenza™ nda

* Ocular Therapeutix inc says outstanding items pertain to form fda-483 close-out of manufacturing deficiencies and analytical testing

* Ocular Therapeutix inc says complete response letter states that fda has determined that it cannot approve nda in its present form

* Ocular Therapeutix -crl acknowledges receipt of co’s nda amendment dated july 10, 2017 and states amendment was not reviewed prior to fda’s action of crl

* Ocular Therapeutix Inc says as a result, fda did not have opportunity to review company’s close-out response prior to issuing crl

* Ocular Therapeutix -FDA indicated applicable sections of amendment submitted by ocular could be incorporated when responding to deficiencies noted in crl

* Ocular Therapeutix Inc says satisfactory resolution of manufacturing deficiencies detailed in form fda-483 is required before nda may be approved

* Ocular Therapeutix -fda’s letter did not identify any efficacy or safety concerns with respect to clinical data for dextenza provided in nda

* Ocular Therapeutix -fda’s letter did not identify any need for additional clinical trials for nda approval Source text for Eikon: Further company coverage:

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