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New Drug Application (NDA)

FDA accepts New Drug Application for Eyenovia pupil dilation tech

March 2, 2021 By Sean Whooley

Eyenovia - updated logo

Eyenovia (NSDQ:EYEN) announced today that the FDA accepted its New Drug Aplication for its MydCombi pupil dilation agent. MydCombi is a fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience, according to a news release. New York-based Eyenovia’s proprietary Optejet […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: Eyenovia Inc., FDA, New Drug Application (NDA)

Avedro application needs more work, FDA says

March 18, 2014 By drugdelivery

Avedro application need more work, FDA says

Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: Avedro Inc., New Drug Application (NDA)

pSivida takes another stab at FDA approval for Iluvien

March 27, 2013 By drugdelivery

pSivida

Alimera Sciences

It’s been a rocky road for pSivida‘s (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.

Filed Under: Drug-Device Combinations Tagged With: Alimera Sciences, New Drug Application (NDA), pSivida Corp.

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