FDA approves Hi-Tech Pharmacal’s generic ophthalmic solution

The U.S. Food and Drug Administration has given the final approval to Hi-Tech Pharmacal Company’s dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt®. Indicated for lessening elevated intraocular pressure in patients suffering from ocular hypertension or open-angle glaucoma, the generic solution will be launched in the markets soon. Hi-Tech Pharmacal Co. Inc. specializes in manufacturing semi-solid and liquid dosage forms of sterile ophthalmic and inhalation products.

CHMP recommends Azarga for approval

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on recommendation for approval to grant a marketing authorisation for Alcon Laboratories’ Azarga 10 mg/ml / 5 mg/ml Eye drops. The suspension will be a more effective treatment of elevated intraocular pressure for adult patients suffering from ocular hypertension or open-angle glaucoma who have not benefited much from mono-therapy.The drug is a fixed combination of Timolol and Brinzolamide. These compounds reduce the production of aqueous humor by inhibiting the conversion of CO2 to bicarbonate in the eye’s ciliary body, hence controlling IOP.