PHILADELPHIA, Dec. 14 /PRNewswire-FirstCall/ -- Lannett(R) Company, Inc. is delighted to announce that Jerome Stevens Pharmaceutical, Inc. (JSP), Lannett's exclusive supplier, has received a letter from the Food and Drug Administration (FDA) approving the bioequivalence of its Levothyroxine Sodium Tablet to Synthroid(R), which is marketed by Abbott Laboratories Inc.
Levothyroxine Sodium Tablets are used to treat hypothyroidism and other thyroid disorders. It is one of the most prescribed drugs in the United States with over 13 million patients. According to market research, the annual retail sales for Synthroid(R) are approximately $800 million.
A Lannett spokesperson stated, "This approval will now allow pharmacists to substitute Lannett's Levothyroxine Sodium Tablets for both dominant brands. Previously, in a June press release we announced the FDA's granting of an AB rating to Levoxyl marketed by King Pharmaceuticals. The total market for both brands exceeds 1.3 billion dollars annually and represents the 2nd most prescribed drug in America."
Lannett's common stock trades on the American Stock Exchange under the symbol "LCI". For more information, please call Investor Relations at 215/333-9000.
This press release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statements that refer to Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, or other non- historical facts are forward-looking and reflect Lannett's current perspective of existing trends and information. These statements involve risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward- looking statements. Such risks and uncertainties include, among others, the uncertainty that actual results may differ materially from the preliminary results described in this press release, rates of sale of customer inventories, the success of Lannett's product development activities and the timeliness with which regulatory authorizations and product roll-out may be achieved, market acceptance of Lannett's products and the impact of competitive products and pricing, the availability on commercially reasonable terms of raw materials and other third party sourced products, successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions, exposure to product liability and other lawsuits and contingencies, and other risks and uncertainties detailed in Lannett's most recent filings with the Securities and Exchange Commission, including but not limited to: Lannett's Annual Report and Form 10-K for the year ended June 30, 2004.
Lannett Company, Inc.