29.06.2007 16:07:00
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Teva Announces Approval of Amlodipine Besylate Tablets
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has granted approval for the
company’s ANDA for Amlodipine Besylate
Tablets, 2.5 mg, 5 mg and 10 mg. Shipment of the product will begin
shortly.
Teva’s Amlodipine Besylate Tablets are the
AB-rated generic equivalent of Pfizer’s Norvasc® Tablets, and are indicated for treatment of hypertension, chronic
stable angina and vasospastic angina. Mylan has sued the FDA arguing
that its 180-day exclusivity blocks other final approvals until
September, 2007.
Total annual sales of this product are approximately $2.8 billion for
the twelve months ended March 31, 2007, based on IMS sales data.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among
the top 20 pharmaceutical companies in the world and is the 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 76 percent of Teva's sales are in North America and
Europe.
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 Teva’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 risks relating to: Teva's ability
to successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which Teva may obtain U.S. market exclusivity for certain of its new
generic products and regulatory changes that may prevent Teva 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®, Neurontin®
and Lotrel®, the effects of competition on our
innovative products, especially Copaxone®
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, Teva’s ability to
successfully identify, consummate and integrate acquisitions, 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 Teva’s
Annual Report on Form 20-F 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 or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
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