Generic pharmaceutical company DifGen Pharmaceuticals announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for Fluorometholone Ophthalmic Suspension, 0.1%, a complex generic formulation used to treat eye inflammation.
This is only the second generic FDA approval of this complex suspension product, DifGen said.
Fluorometholone Ophthalmic Suspension is a corticosteroid indicated for treating steroid-responsive inflammatory conditions of the eye's anterior segment.
Ramandeep Singh Jaj and Santhanakrishnan Srinivasan, DifGen Pharmaceuticals founders and co-CEO's, said: "We are extremely proud that we received this first cycle approval, which marks a significant milestone for DifGen, demonstrating our expertise in developing complex ophthalmic suspension products with a high regulatory threshold for demonstration of therapeutic equivalence."
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