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Generic brimonidine gets U.S. approval

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FORT WORTH, Texas — A generic version of the glaucoma drug brimonidine tartrate has been approved for marketing by the Food and Drug Administration.

Falcon Pharmaceuticals, an affiliate of Alcon Inc., received U.S. regulatory approval to market brimonidine tartrate ophthalmic solution 0.2% on Tuesday. According to an Alcon press release, the generic drug is therapeutically equivalent to Alphagan (brimonidine tartrate, Allergan).

The generic drug is now approved for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, according to the press release. It will be available immediately in three doses: 5 mL, 10 mL and 15 mL, according to the release.

Allergan stopped marketing its Alphagan 0.2% formulation when it introduced Alphagan P (brimonidine tartrate 0.15%) a lower concentration formulation preserved with Purite.