APP Receives Expedited Approval for the First and Only Generic Cefotetan Disodium for Injection
10 August 2007 - 10:05PM
Business Wire
Abraxis Pharmaceutical Products (APP), the hospital-based business
of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced the
approval from the U.S. Food and Drug Administration (FDA) to market
Cefotetan Disodium for Injection, the generic equivalent of
AstraZeneca�s Cefotan�. Cefotetan has the longest half-life of any
first or second generation cephalosporin and offers surgeons a
convenient single-dose option for surgical prophylaxis and
secondary infections. APP, now as the only supplier of this drug,
expects to launch this important anti-infective back into the
market this month. Based on previous IMS data, Cefotetan has market
potential in excess of $40 million. �As a surgeon, I am very
excited to have Cefotetan back in our arsenal. Its anaerobic
coverage, single-dose administration and long half-life make it a
unique and valuable surgical prophylactic,� said Marc Singer, M.D.,
assistant professor of surgery at the University of Illinois at
Chicago. �Access to this drug will help surgeons prevent
post-operative infections, which, if not successfully prevented,
can have serious consequences resulting in illness or even death.�
�In addition, compliance with peri-operative antibiotic
administration has become a strictly monitored quality assurance
measure. With Cefotetan, we may not need to re-dose in the
operating room which will ultimately help to improve both patient
safety and compliance,� continued Singer. Evidence-based treatment
guidelines reported by the American Society of Health-System
Pharmacists (ASHP) indicate that Cefotetan is the preferred agent
for abdominal or vaginal hysterectomy and cesarean section, and is
recommended for colorectal surgery. In 2006, AstraZeneca�s Cefotan
was withdrawn from the marketplace due to issues with sourcing of
raw material. �We have secured a new, alternate raw material
supplier versus the company previously utilized by the innovator
and are confident in their experience in cephalosporin raw material
manufacturing and ability to provide consistent supply," said
Thomas Silberg, president of Abraxis Pharmaceutical Products. "APP
already markets an anti-infective portfolio that is unmatched. The
addition of Cefotetan to this product line has the potential to
bolster APP's leadership position in this category.� As a
second-generation cephalosporin, Cefotetan is administered prior to
surgery to help prevent surgical prophylaxis and secondary
infection following certain abdominal and gynecological procedures
such as colorectal surgery, vaginal or abdominal hysterectomies and
cesarean sections. Cefotetan is also indicated for treating and
preventing infections elsewhere in the body that are proven or
strongly suspected to be caused by susceptible bacteria, including
urinary tract infections, lower respiratory tract infections, skin
and skin structure infections, gynecologic infections,
intra-abdominal infections and bone and joint infections. Cefotetan
will initially be available in 1g and 2g vials. The product is
AP-rated and preservative free, and each vial will include a bar
code and latex-free vial stopper. Cefotetan for Injection is
indicated for preoperative administration of surgical procedures
that are classified as clean contaminated or potentially
contaminated (e.g., cesarean section, abdominal or vaginal
hysterectomy, transurethral surgery, biliary tract surgery, and
gastrointestinal surgery). The adverse event profile of Cefotetan
for Injection is similar to that of other cephalosporin
antibiotics. The following adverse events were reported in clinical
studies: gastrointestinal, 1.5%; hematologic, 1.4%; hepatic, 1.2%;
hypersensitivity, 1.2%; local, 1.0%. About Abraxis Pharmaceutical
Partners (APP) APP is a specialty drug company that develops,
manufactures and markets injectable pharmaceutical products,
focusing on hospital-based anti-infective, critical care, oncology
and anesthetic/analgesic markets. With products totaling over 400
dosage forms and a market-leading pipeline, APP offers patients and
healthcare providers one of the broadest portfolios of injectable
products in the United States. On July 2, 2007, parent company
Abraxis BioScience (Nasdaq:ABBI) announced that APP and its
proprietary business will become separate independent public
companies, subject to the satisfaction of various closing
conditions, to enable the two business units to concentrate on
their core competencies and compete more effectively in their
respective marketplaces. APP is headquartered in Schaumburg, IL.
For more information, visit www.appdrugs.com. 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� 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�, was
launched in 2005 for the treatment of metastatic breast cancer.
Abraxis trades on the Nasdaq Global Market under the symbol ABBI.
For more information about the company and its products, please
visit www.abraxisbio.com.
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