Abraxis BioScience Receives FDA Approval for Ampicillin and Sulbactam for Injection, 15g, USP.Approval Marks the Tenth Received by the Company's Hospital-Based Division in 2006 LOS ANGELES -- Abraxis BioScience, 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 : ABBI Advanced Breast Biopsy Instrument (ABBI) Uses a rotating circular knife and thin heated electrical wire to remove a large cylinder of abnormal breast tissue. Mentioned in: Fibrocystic Condition of the Breast ), an integrated, global biopharmaceutical company, 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. ) for 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 the combination drug Ampicillin ampicillin (ăm'pĭsĭl`ĭn), a penicillin-type antibiotic that is effective against both gram-negative microorganisms and gram-positive microorganisms such as Escherichia coli. and Sulbactam for Injection, 15g, USP USP - unique sales point , the generic equivalent of Pfizer Inc.'s Unasyn([R]). According to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data, annual sales in 2005 of this product exceeded $10.4 million. The company's hospital-based products division, Abraxis Pharmaceutical Products (APP), expects to commence marketing Ampicillin and Sulbactam, 15g immediately. With this approval, APP now offers the complete line of Ampicillin and Sulbactam, which includes the 15g pharmacy bulk pack (PBP) and 1.5g and 3g single-dose vials (SDV). The product is AP rated and latex-free. The approval is the tenth product approval the company has received this year. Ampicillin and Sulbactam is an injectable antibacterial combination consisting of the seminsynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium. Administered intravenously or intramuscular intramuscular /in·tra·mus·cu·lar/ (-mus´ku-ler) within the muscular substance. in·tra·mus·cu·lar adj. Abbr. IM Within a muscle. , Ampicillin and Sulbactam is indicated for the treatment of several skin and skin structure, intra-abdominal and gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. infections due to susceptible strains of microorganisms. APP manufactures and markets one of the largest anti-infective injectable product portfolios and one of the broadest portfolios of oncology and critical care injectable products. APP, with its 350 dosage forms currently manufactured and marketed, the ten FDA approvals received in 2006, and the 26 ANDA's currently under review by the FDA, is positioned to be one of the largest suppliers of injectable pharmaceutical products for critically ill patients. About Abraxis BioScience, Inc. Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab[TM] platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE([R]), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com. Forward-Looking Statement The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding immediate commencement of marketing Ampicillin and Sulbactam. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the market adoption and demand of Ampicillin and Sulbactam, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2005 and other documents it has filed with the Securities and Exchange Commission. The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments. Unasyn([R]) is a registered trademark of Pfizer Inc. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion