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 Codeine Sulfate Tablets USP, a schedule II controlled substance, 15 mg, 30 mg and 60 mg, the therapeutic equivalent to the reference listed drug, Codeine Sulfate Tablets USP 15 mg, 30 mg and 60 mg, of Roxane Laboratories, Inc. According to IMS, for the year ended April 2014 total sales of Codeine Sulfate Tablets USP 15 mg, 30 mg and 60 mg at Average Wholesale Price (AWP) were approximately $4.3 million. The company expects to commence shipping the product in the coming months.
“Codeine Sulfate Tablets USP 15 mg, 30 mg and 60 mg is our second product approved by the FDA thus far in 2014,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “We currently have a number of product applications pending at the FDA and are hopeful to receive additional product approvals in the coming months. In addition, we continue to develop our pipeline, which includes 55 products in various stages of development.”
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 Codeine Sulfate Tablets USP 15 mg, 30 mg and 60 mg, 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.