Accentia Biopharmaceuticals Receives FDA Approval for Three Unique Dosage Combination Pain Product ANDAs; Accentia's Portfolio Expands to Six Products Intended to Reduce the Risk of Toxicity.TAMPA, Fla. -- Accentia Biopharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ABPI ABPI Association of the British Pharmaceutical Industry ABPI Associação Brasileira da Propriedade Intelectual (Brazilian Intellectual Property Association; Brazil) ABPI Ankle Brachial Pressure Index ) and its development partner have received approval from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) for three additional combination pain product ANDAs (Abbreviated New Drug Applications), broadening the Company's pain product portfolio to better serve physicians in managing their patients, especially those with chronic pain. TEAMM Pharmaceuticals, Inc., Accentia's wholly owned specialty pharmaceutical subsidiary, holds the exclusive U.S. license for the marketing and sale of these three new formulations. "Our sales force has been very effective in establishing our presence in the pain market with our Xodol (hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen Warning - High-alert drug! Anexsia, Ceta-Plus, Co-Gesic, Hydrocet, Lorcet-HD, Lortab, Vicodin, Vicodin HP Pharmacologic class: tablets, USP USP - unique sales point ) brand for the treatment of moderate to moderately severe pain," said Gary Cantrell, TEAMM Pharmaceuticals Executive Vice President of Sales and Marketing. "The addition of these three new combination narcotic and analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs products increases our comprehensive pain product portfolio to six, positioning the Company to more effectively compete in an even larger segment of the chronic pain market." Each year, in the United States alone, 45 million pain product prescriptions are written for the treatment of pain, ranging from mild and acute to severe, debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction and chronic. About Accentia Biopharmaceuticals, Inc. Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase(TM) and BiovaxID(TM). The Company's SinuNase product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary, Biovest International, Inc., is currently in a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. . In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, please visit our web site: www.accentia.net. Forward-Looking Statements Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Xodol and any other statements relating to products, product candidates, and product development programs. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and Accentia does not undertake any obligation to revise or update this news release to reflect events or circumstances after the date hereof. |
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