FDA approves generic solution of dorzolamide with timolol
The U.S. Food and Drug Administration approved Lannett Company’s abbreviated new drug application for dorzolamide hydrochloride and timolol maleate ophthalmic solution 2%/0.5%.
The solution is the generic equivalent to Cosopt (Oak Pharmaceuticals).
“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,” Arthur P. Bedrosian, CEO of Lannett, said in a press release. “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.”