Lannett Company Receives Approval for Doxycycline Monohydrate.PHILADELPHIA -- Lannett Company, Inc. (AMEX AMEX See: American Stock Exchange :LCI LCI Livable Centers Initiative LCI Life Cycle Inventory LCI Landing Craft, Infantry LCI La Chaine Info (French cable news channel) LCI Lean Construction Institute LCI Lions Club International ), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) of its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for Doxycycline Monohydrate Tablets 50mg and 100mg; the first generic approval of this product. Doxycycline Monohydrate is the generic version of Adoxa(R), marketed by Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals, Inc. According to NDC NDC National Drug Code NDC NATO Defense College NDC National Documentation Centre (National Hellenic Research Foundation, Athens, Greece) NDC National Dairy Council NDC National Democratic Congress Health, total sales of Adoxa were $32 million in 2004. Doxycycline Monohydrate is a tetracycline-type antibiotic used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea gonorrhea (gŏnərē`ə), common infectious disease caused by a bacterium (Neisseria gonorrhoeae), involving chiefly the mucous membranes of the genitourinary tract. , chlamydia, periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. and others. About Lannett Company: Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit Lannett Company's website at www.lannett.com. This news release contains certain forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Lannett's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Lannett's ability to successfully develop products; the impact of competition from brand name companies that sell their own generic products or successfully extend the exclusivity period of their branded products; the availability of product liability coverage in the current insurance market; the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals; acceptance and demand for new pharmaceutical products and new therapies; uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development; the impact of restructuring of clients; reliance on strategic alliances; exposure to product liability claims; dependence on patent and other protections for innovative products; fluctuations in currency, exchange and interest rates; and operating results and other factors that are discussed in Lannett's Annual Report on Form 10-K for its fiscal year ended June 30, 2005, and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. |
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