- Tags: FDA
Products
Alcon voluntarily recalls Systane Lubricant Eye Drops Ultra PF
Late last month, the FDA reported a potential risk for fungal contamination associated with one lot of the preservative-free eye drops.
Pipeline
FDA accepts Lenz Therapeutics’ NDA for presbyopia eye drops
PDUFA target action date on LNZ100 (1.75% aceclidine) is set for August 2025
Products
FDA grants tentative approval for Lupin's Lumify generic eye drops
Brimonidine tartrate ophthalmic solution, 0.025% is indicated to treat ocular redness due to minor irritations in the eye.
Products
FDA issues warning against unapproved B+L copycat eye drops
Sample testing has identified bacterial contamination from products falsely marketed as a generic formulation of LUMIFY eye drops.
Products
FDA issues new warnings and guidance on OTC eye drops
Agency updates consumer tips and recommendations after a busy year of product recalls and warnings.
Products
Initial FDA inspection findings of recalled eye drops manufacturer indicate 14 problems
Agency reports unsanitary facility conditions and omitted/falsified contamination and sterility test results, among other violations.
Products
Amazon receives FDA warning for selling 7 unapproved eye drops
Agency cites numerous federal violations and significant public health concerns.
Products
FDA issues warning against use of two MSM eye drops
Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops are at the center of the latest recall.
Legal
FDA warns against use of unapproved amniotic fluid eye drops
Notification follows letters to Regener-Eyes and M2 Biologics for invalidated DED products on the market.
Products
FDA approves Gland Pharma's OTC Extra Strength Pataday generic
Olopatadine HCl ophthalmic solution 0.7% is indicated to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander for 24 hours.
Pipeline
FDA extends reproxalap's PDUFA to March 2026
Updated target action date applies to Aldeyra’s third NDA submission of the investigational DED eye drop.
Pipeline
Cloudbreak advances vascularized pinguecula eye drop to phase 3 trials
Company’s investigational multi-kinase inhibitor targeting VEGFs and PD-GFRs met phase 2 primary endpoint of conjunctival hyperemia earlier this year
Products
FDA approves Alembic Pharma's loteprednol etabonate and tobramycin ophthalmic suspension
Generic of Bausch + Lomb’s ZYLET for steroid-responsive inflammatory ocular conditions qualifies for 6 months of market exclusivity once commercially launched.
Products
Amneal receives FDA approval for Restasis generic
Generic version of Allergan’s cyclosporine ophthalmic emulsion 0.05% eye drop for dry eye is the second to receive U.S. regulatory clearance.
Pipeline
Ocuvex resubmits FDA CRL for brimonidine tartrate 0.35% NDA
Shared by partner SPARC, update follows 2+ years after the 2022 submission of investigational OAG and OHT eye drop was rejected in July 2023.
Pipeline
FDA rejects Sydnexis’ NDA for low-dose atropine drop
SYD-101 still has the potential to become the first pharmaceutical option for progressive myopia for patients aged 3 to 14.
Products
FDA approves FDC Limited's pilocarpine HCl ophthalmic solution
ANDA approval for generic eye drop extends to three concentrations: 1%, 2%, and 4%.
Products
FDA approves Amneal's bimatoprost 0.01% generic
Generic version of Allergan’s LUMIGAN is indicated for reducing elevated IOP in glaucoma and ocular hypertensive patients.
Legal
FDA issues Scope Health warning letter over OPTASE ophthalmic products
Agency names Allegro, MGD Advanced, and Dry Eye Intense eye drops among products identified as unapproved new drugs and misbranded.
Products