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BRIEF-Ocular Therapeutix submits amendment to potentially extend review for Dextenza NDA
2017年7月10日 / 晚上8点23分 / 1 个月前

BRIEF-Ocular Therapeutix submits amendment to potentially extend review for Dextenza NDA

July 10 (Reuters) - Ocular Therapeutix Inc

* Ocular Therapeutix submits amendment to potentially extend review for Dextenza New Drug Application (NDA)

* Ocular Therapeutix Inc - Requesting FDA to consider submission a major amendment and extend current NDA target action date of July 19, under PDUFA

* Ocular Therapeutix - extend current NDA target action date of July 19, under PDUFA by 3 months and to review submission during current review cycle

* Ocular Therapeutix Inc - Ocular Therapeutix submitted a close-out response to all inspectional observations included in FDA form 483

* Ocular Therapeutix Inc - submitted details of a manufacturing equipment change as an amendment to NDA resubmission for Dextenza 0.4 mg

* Ocular Therapeutix Inc - Ocular Therapeutix has modified a piece of manufacturing equipment referenced in NDA resubmission Source text for Eikon: Further company coverage:

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