Policy & Regulation
Formosa Pharmaceuticals and Apotex sign Mexico licensing agreement for clobetasol propionate ophthalmic suspension
7 May 2025 -

Taiwan-based Formosa Pharmaceuticals (TW:6838) announced on Tuesday that the company has entered into an exclusive licensing agreement with Apotex Inc, a Canadian pharmaceutical company, for exclusive rights in Mexico for the commercialisation of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery.

The product was approved by the US Food and Drug Administration (FDA) in 2024. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform. The novel formulation is designed to enable a convenient and straightforward dosing regimen, while providing rapid and sustained relief of inflammation and pain, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p

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