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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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UPDATED
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Watson Labs Ciprofloxacin Ophthalmic Solution (ANDA 076673)
FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.
UPDATED
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Apotex Latanoprost Ophthalmic Solution (ANDA077697)
The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.
UPDATED
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ECONOPRED Ophthalmic Suspension (NDA 017468) – Discontinued
The FDA approved ECONOPRED, a 0.125% prednisolone acetate ophthalmic suspension, under NDA 017468 with multiple manufacturing submissions and a 2003 labeling approval. The product is now listed as discontinued.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA084306 for MYDRIACYL (Tropicamide 1% Ophthalmic Solution)
The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.
UPDATED
Regulatory Updates
Aug 27, 2026•1 min read
FDA Announces Discontinued Ophthalmic Ointment DEXAIR (ANDA088071)
The FDA’s ANDA088071 filing shows that DEXAIR ophthalmic ointment, containing 0.05% dexamethasone sodium phosphate, is marked discontinued by sponsor PharmaFair.
UPDATED
Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves ANDA078395 for Dorzolamide Hydrochloride Ophthalmic Solution
The FDA has approved ANDA078395 for a 2% Dorzolamide Hydrochloride ophthalmic solution marketed by Advagen Pharma Ltd., with Rubicon Research as sponsor.