Fierce Pharma March 5, 2024
Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid.
Monday, the U.S. FDA granted approval to Formosa and AimMax Therapeutics’ clobetasol propionate ophthalmic suspension 0.05% to treat post-operative inflammation and pain following eye surgery.
The drug utilizes a potent corticosteroid modified with Formosa’s APNT nanoparticle formulation platform, which makes it possible to administer to the eye via a twice-daily dosing regimen, the companies said in a release.
Clobestasol propionate is a prednisolone derivative that snared its first FDA approval on Dec. 27, 1985. As a topical steroid, the drug is used to treat multiple skin conditions such as eczema, psoriasis, allergies and rash.
The FDA based its recent approval on two phase 3...
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