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PHILADELPHIA — Lannett Co. has received approval from the Food and Drug Administration for dorzolamide hydrochloride and timolol maleate ophthalmic solution (2%/0.5%).
Lannett said Thursday that its product is a generic equivalent of Cosopt Ophthalmic Solution (2%/0.5%) from Oak Pharmaceuticals Inc.
The eye drop medication is used to treat glaucoma and other causes of high pressure inside the eye.
Sales of dorzolamide hydrochloride and timolol maleate ophthalmic solution (2%/0.5%) at average wholesale price (AWP) totaled about $123 million for the year ended in October, according to IMS Health data reported by Lannett.
"Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution 2%/0.5% adds a new dosage form to our product offering," stated Arthur Bedrosian, chief executive officer of Lannett. "The addition of this product exemplifies our team’s capabilities to develop and manufacture medications in a wide variety of forms, including solid orals in both immediate and extended-release, topicals, oral solutions, parenterals and now ophthalmics. This approval represents our fourth product approved by the FDA thus far in fiscal 2015. We expect to commence shipping the product in the coming months."
