Last Updated on October 6, 2024 by The Health Master
New Delhi: Eyenovia Inc said on Monday the U.S. Food and Drug Administration (USFDA) had approved its pupil-dilating spray to be used with the company’s proprietary drug delivery device during eye examinations.
The spray is indicated for mydriasis, or pupil dilation, for eye examinations carried out before cataract surgery or corrective prescriptions.
The U.S. health regulator had reclassified the drug, Mydcombi, as a drug-device combination product in 2021, given its dependence on Eyenovia’s experimental drug delivery device Optejet for administration.
The agency had declined to approve the spray in its then-form as a standalone drug and requested additional device testing for the Optejet dispenser.
The USFDA had not requested any additional clinical work for Mydcombi drug.
Advt “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024,” Michael Rowe, chief executive officer of Eyenovia, said in a statement.
USFDA gives approval for this first RSV Vaccine
USFDA gives tentative nod for ARV oral, Dolutegravir
USFDA gives approval for next generation Pneumococcal Vaccine
USFDA gives approval for this ALS drug
USFDA gives nod for Nitrofurantoin Oral Suspension USP
NPPA to fix ceiling prices based on existing methodology
Drug recall: 24,194 Prefilled Syringes of generic medication recalled due to this reason
NABL accredits more Laboratories with a total number of 8,386 Laboratories
National Medical Devices Policy 2023: Salient Features
Nitrosamine content high in some drugs
IPC invites laboratories to join Testing Programme for quality assurance
All Blood Centres / Banks to have NAT-PCR test by 2025
Moving towards zero counterfeiting to ease traceability and authentication
Drug alert: 48 out of 1497 samples declared as NSQ in March 2023
Wet Granulation vs Dry Granulation: Understanding the Key Differences
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: