Lannett Receives FDA Approval for Dorzolamide HCL with Timolol
Philadelphia, PA – December 18, 2014 – Lannett Company, Inc. (NYSE: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5%, the therapeutic equivalent to the reference listed drug, Cosopt® Ophthalmic Solution, 2%/0.5%, of Oak Pharmaceuticals, Inc.. According to IMS, for the year ended October 2014 total sales of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5%, at Average Wholesale Price (AWP) were approximately $123 million.
“Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5%, adds a new dosage form to our product offering,” said Arthur P. 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.”
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company’s website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, successfully commercializing Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5%, and the receipt of product approvals in coming months, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company’s Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.