FDC LIMITED

FDC Limited Receives FDA Approval for Generic Pilocarpine HCl Ophthalmic Solution

- FDC Limited has received FDA approval for its abbreviated new drug application (ANDA) for pilocarpine hydrochloride ophthalmic solution in three concentrations (1%, 2%, and 4%). - The generic ophthalmic solution is indicated for multiple conditions including reduction of elevated intraocular pressure in glaucoma patients, management of acute angle-closure glaucoma, and induction of miosis for presbyopia. - This approval allows the India-based pharmaceutical company to market the generic version in the United States, potentially expanding access to this established glaucoma and presbyopia treatment. - The approval follows recent launches of brand-name pilocarpine products including Vuity from Allergan/AbbVie and QLOSI from Orasis Pharmaceuticals for presbyopia treatment.