FDC has received the Food and Drug Administration’s approval for dorzolamide and timolol ophthalmic solution in a dosage strength of 22.3mg/6.83mg per ml.
The product is a generic of Oak Pharmaceutical’s Cosopt.
It is indicated for the reduction of elevated intraocular pressure, or IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time).