-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, LKJR3xWm0aab+AYtXFAHelb2XPXOmI2tnSSyNHJVEiPVygqUNAJYTYHvISztCpgi 68yxdHXMXeZkb4FBx5o6pQ== 0000818686-10-000065.txt : 20100629 0000818686-10-000065.hdr.sgml : 20100629 20100629090539 ACCESSION NUMBER: 0000818686-10-000065 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090401 FILED AS OF DATE: 20100629 DATE AS OF CHANGE: 20100629 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TEVA PHARMACEUTICAL INDUSTRIES LTD CENTRAL INDEX KEY: 0000818686 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16174 FILM NUMBER: 10921604 BUSINESS ADDRESS: STREET 1: 5 BAZEL ST STREET 2: P O B 3190 CITY: PETACH TIKVA STATE: L3 ZIP: 49131 MAIL ADDRESS: STREET 1: TEVA PHARMACEUTICAL INDUSTRIES LIMITED STREET 2: 5 BAZEL ST PO B 3190 CITY: PETACH TIKVA STATE: L3 ZIP: 49131 6-K 1 venlafaxine290610.htm TEVA ANNOUNCES APPROVAL OF GENERIC EFFEXOR XR? venlafaxine290610

     Website: www.tevapharm.com

For immediate release

Teva Announces Approval of Generic Effexor XR®

Jerusalem, June 29, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company`s generic version of Wyeth`s antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.

As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.

 

Teva's 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, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel® and Protonix®, the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone® (including potential generic and oral competition for Copaxone®), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").

###

 

Contacts:

Investor Relations:
Elana Holzman
Teva Pharmaceutical Industries Ltd.
972 (3) 926-7554

Kevin Mannix
Teva North America
(215) 591-8912

Media:
Yossi Koren
Teva Pharmaceutical Industries Ltd.
972 (3) 926-7590

Denise Bradley
Teva North America
(215) 591-8974

 

 

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