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Dextenza Approval History

FDA Approved: Yes (First approved December 3, 2018)
Brand name: Dextenza
Generic name: dexamethasone
Dosage form: Ophthalmic Insert
Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain.

Development History and FDA Approval Process for Dextenza

DateArticle
Dec  3, 2018Approval FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
Jun 29, 2018Ocular Therapeutix Announces NDA Resubmission of Dextenza
Jul 11, 2017Ocular Therapeutix Receives Complete Response Letter from FDA for Dextenza NDA
Feb 22, 2017Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery
Jan 23, 2017Ocular Therapeutix Resubmits NDA for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery
Nov 20, 2016Ocular Therapeutix Announces Successful Topline Results for Both Inflammation and Pain Primary Efficacy Endpoints from Phase 3 Clinical Trial of Dextenza
Jul 25, 2016Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Dec  9, 2015Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain
Sep 28, 2015Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Jun 16, 2015Ocular Therapeutix Begins Enrollment in Phase 3 Clinical Trial for Dextenza for the Treatment of Allergic Conjunctivitis

Further information

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