Lannett Company Receives FDA Approval for Primidone 50 Mg Tablets
TUESDAY, MAY 29, 2001 8:38 AM
- PRNewswire
PHILADELPHIA, May 29, 2001 /PRNewswire via COMTEX/ -- Lannett Company, Inc. (OTC:LANN), a pharmaceutical manufacturer, announced that the Food and Drug Administration has approved its abbreviated new drug application ("ANDA") for Primidone Tablets USP, 50 mg, a generic version of Elan's Mysoline, indicated for epileptic seizures.
Lannett is currently working on many new prescription product offerings. The company's current and pipeline products serve a diverse range of medical treatments, including Attention-Deficit-Hyperactivity-Disorder, Pain Management, Irritable Bowel Syndrome, Allergies, Weight Management, Epilepsy, and AIDS. Lannett has approximately 90 employees and manufactures both prescription and over-the-counter generic drugs.
Lannett, one of the country's first pharmaceutical manufacturers, has reinvigorated its new product development activities. It has positioned itself as a high quality manufacturer of niche products with limited generic competition.
"Lannett has made its top priority the identification, research and development of niche products with little or no generic competition," says Larry Dalesandro, Chief Operating Officer of Lannett. "These drugs generally fall below the radar of the large manufacturers. As a result, the price erosion is not as severe, and product profitability is higher."
"In addition to higher profit margins, a product like this will allow us to open new accounts with some of the largest retail chains and distribution wholesalers in the industry," adds Dalesandro. "The current annual sales for Mysoline 50 mg Tablets are approximately $12 million."
William Farber, Chairman of the Board of Directors, states, "This approval is just the beginning of Lannett's new product introductions, and previous ANDA re-introductions. We have invested resources in research and development activities. We are committed to increasing our product line, and gaining a more competitive position in the generic market. We expect many new approvals over the next few years."
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, 2000.
The Company's common stock trades in the over-the-counter market through the use of the inter-dealer "pink sheets," published by the National Quotations Bureau, Inc. under the symbol ("LANN"). For more information please call Larry Dalesandro at 215-333-9000.
TUESDAY, MAY 29, 2001 8:38 AM
- PRNewswire
PHILADELPHIA, May 29, 2001 /PRNewswire via COMTEX/ -- Lannett Company, Inc. (OTC:LANN), a pharmaceutical manufacturer, announced that the Food and Drug Administration has approved its abbreviated new drug application ("ANDA") for Primidone Tablets USP, 50 mg, a generic version of Elan's Mysoline, indicated for epileptic seizures.
Lannett is currently working on many new prescription product offerings. The company's current and pipeline products serve a diverse range of medical treatments, including Attention-Deficit-Hyperactivity-Disorder, Pain Management, Irritable Bowel Syndrome, Allergies, Weight Management, Epilepsy, and AIDS. Lannett has approximately 90 employees and manufactures both prescription and over-the-counter generic drugs.
Lannett, one of the country's first pharmaceutical manufacturers, has reinvigorated its new product development activities. It has positioned itself as a high quality manufacturer of niche products with limited generic competition.
"Lannett has made its top priority the identification, research and development of niche products with little or no generic competition," says Larry Dalesandro, Chief Operating Officer of Lannett. "These drugs generally fall below the radar of the large manufacturers. As a result, the price erosion is not as severe, and product profitability is higher."
"In addition to higher profit margins, a product like this will allow us to open new accounts with some of the largest retail chains and distribution wholesalers in the industry," adds Dalesandro. "The current annual sales for Mysoline 50 mg Tablets are approximately $12 million."
William Farber, Chairman of the Board of Directors, states, "This approval is just the beginning of Lannett's new product introductions, and previous ANDA re-introductions. We have invested resources in research and development activities. We are committed to increasing our product line, and gaining a more competitive position in the generic market. We expect many new approvals over the next few years."
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, 2000.
The Company's common stock trades in the over-the-counter market through the use of the inter-dealer "pink sheets," published by the National Quotations Bureau, Inc. under the symbol ("LANN"). For more information please call Larry Dalesandro at 215-333-9000.
