Oct 20 2008, 12:23 PM EST
News source: Business Wire
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today
that the U.S. Food and Drug Administration has granted approval for
the Company's Abbreviated New Drug Application (ANDA) for Fentanyl
Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100
mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic
pain treatment Duragesic(R). Shipment of this product has commenced.
Total annual sales of this product for the strengths noted above,
including both brand and generic sales, were approximately $1.2
billion in the United States for the twelve months that ended June 30,
2008, based on IMS sales data.
Teva's Fentanyl Transdermal System was developed and manufactured
by Aveva Drug Delivery Systems, a Nitto Denko company, which is one of
the world's largest manufacturers of, and a pioneer in, "drug in
adhesive" transdermal patch technology. The product utilizes a
proprietary matrix design which incorporates the drug into the
adhesive. It is indicated for the management of persistent moderate to
severe chronic pain that requires continuous, around-the-clock opioid
administration for an extended period of time and that cannot be
managed by other means such as non-steroidal analgesics, opioid
combination products, or immediate-release opioids.
FDA's diligence in approving this ANDA ensures that patients
continue to have access to this medicine.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 pharmaceutical companies in the world and is the
world's leading generic pharmaceutical company. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health
pharmaceutical products. Over 80 percent of Teva's sales are in North
America and Europe.
About Aveva Drug Delivery Systems
Aveva Drug Delivery Systems (www.avevadds.com) is a Nitto Denko
company, with a proven track record for providing pharmaceutical
partners with fully integrated, controlled-release transdermal
products. The company offers a pipeline of products for license along
with a full range of research, development and manufacturing
capabilities to produce proprietary and generic transdermal drug
delivery systems. For more information contact Robert J. Bloder at
(954)-624-1374.
Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express
the current beliefs and expectations of management. Such statements
are based on management's current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could cause
our 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 risks relating
to: our ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic
equivalents, the extent to which we may obtain U.S. market exclusivity
for certain of our new generic products and regulatory changes that
may prevent us from utilizing exclusivity periods, competition from
brand-name companies that are under increased pressure to counter
generic products, or competitors that seek to delay the introduction
of generic products, the impact of consolidation of our distributors
and customers, potential liability for sales of generic products prior
to a final resolution of outstanding patent litigation, including that
relating to the generic versions of Allegra(R) , Neurontin(R),
Lotrel(R) and Protonix(R), the effects of competition on our
innovative products, especially Copaxone(R) sales, 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, European Medicines Agency and other
regulatory authority approvals, the regulatory environment and changes
in the health policies and structures of various countries, our
ability to achieve expected results though our innovative R&D efforts,
our ability to successfully identify, consummate and integrate
acquisitions, including the pending acquisition of Barr
Pharmaceuticals Inc., potential exposure to product liability claims
to the extent not covered by insurance, dependence on the
effectiveness of our patents and other protections for innovative
products, significant operations worldwide that may be adversely
affected by terrorism, political or economical instability or major
hostilities, supply interruptions or delays that could result from the
complex manufacturing of our products and our global supply chain,
environmental risks, fluctuations in currency, exchange and interest
rates, and other factors that are discussed in this report and in our
other filings with the U.S. Securities and Exchange Commission
("SEC").
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