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2003 News Releases

Friday, December 19, 2003
Teva Announces Tentative Approval of Terbinafine HCL Tablets

Jerusalem, Israel, December 19, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the company's ANDA for Terbinafine Hydrochloride Tablets, 250 mg. Final approval is anticipated upon expiry of patent protection in December 2006.Teva's Terbinafine HCl Tablets are the AB-rated generic equivalent of Novartis' antifungal agent Lamisil® Tablets.The brand product has annual sales of approximately $541 million.Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceu Read More »

Friday, December 12, 2003
Teva Announces Filing of Universal Shelf Registration Statement

Jerusalem, Israel, December 12, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has filed a universal shelf registration statement with the U.S. Securities and Exchange Commission. The registration statement will allow Teva to offer from time to time up to $2 billion in various types of securities, including ADRs, debt securities, which may be convertible into ADRs, and other securities. The debt securities may be issued by Teva directly or through one or more special purpose finance subsidiaries guaranteed by Teva. Dan Suesskind, Chief Financial Officer of Te Read More »

Wednesday, December 10, 2003
Teva and Andrx Announce Collaboration on Generic Oral Contraceptive Products

Jerusalem, Israel, December 10, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Andrx Corporation (Nasdaq: ADRX) jointly announced today that they have entered into a strategic collaboration to develop and market generic oral contraceptive pharmaceutical products.Under the terms of the agreement, Teva will receive exclusive marketing rights in the U.S. and Canada to Andrx's line of generic oral contraceptive products currently pending regulatory approval. Andrx will be responsible for all formulations, U.S. regulatory submissions, and manufacturing of products covered under the a Read More »

Tuesday, November 25, 2003
Teva Announces Approval of Fosinopril Sodium Tablets 10 Mg, 20 Mg, And 40 Mg

Jerusalem, Israel, November 25, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval of the company's ANDA for Fosinopril Sodium Tablets, 10 mg, 20 mg and 40 mg. This approval follows an October 27, 2003 decision by the U.S. District Court for the Southern District of New York granting judgment in favor of Teva on the issue of non-infringement with regard to Bristol-Myers Squibb's Monopril® Patent No. 5,006,344.As the first company to file an ANDA with a Paragraph IV patent certification for this product Read More »

Sunday, November 23, 2003
Court of Appeals Affirms Teva's Augmentin® Patent Challenge

Jerusalem, Israel, November 23, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Court of Appeals for the Federal Circuit affirmed the May 2002 decision of the U.S. District Court for the Eastern District of Virginia in Teva's successful challenge of GlaxoSmithKline's patent position relating to Augmentin®.Mr. Israel Makov, President and CEO of Teva commented: "Teva is very pleased with this decision, which will allow us to continue to provide a more affordable generic version of Augmentin® to consumers in the United States. We have always believed that we Read More »

Tuesday, November 11, 2003
Teva Announces Continued Convertibility of Its Debentures

Jerusalem, Israel, November 11, 2003 - Teva Pharmaceutical Industries Limited (Nasdaq: TEVA) announced today, as required by the terms under its indentures, that its $360 million in principal amount of 0.75% Convertible Senior Debentures due 2021 and its $450 million in principal amount of 0.375% Convertible Senior Debentures due 2022, each of which were issued by special purpose finance subsidiaries, will remain convertible into Teva's ADRs from November 11, 2003 through February 17, 2004, as a result of the trading price of Teva's ADRs exceeding certain thresholds set forth in the indentures Read More »

Sunday, November 09, 2003
Teva Announces Approval Of Mupirocin Ointment

Jerusalem, Israel, November 9, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Mupirocin Ointment USP, 2%. Shipment of the product will begin immediately.Mupirocin Ointment USP, 2% is the AB-rated generic equivalent of GlaxoSmithKline's Bactroban® Ointment, a topical antibacterial for treatment of impetigo. Annual sales of the brand product are approximately $97 million. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies and among the Read More »

Friday, November 07, 2003
Teva Announces Termination Of Acquisition Discussions With Savient

Jerusalem, Israel, November 7, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it and Savient Pharmaceuticals, Inc. had mutually agreed to terminate their acquisition discussions because they could not reach agreement on terms.Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in Read More »

Friday, November 07, 2003
Teva Announces Tentative Approval Of Benazepril Hcl Tablets, 5 Mg, 10 Mg, 20 Mg, And 40 Mg

Jerusalem, Israel, November 7, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the company's ANDA for Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg. Final approval is anticipated upon expiry of pediatric exclusivity, which protects the brand product until February 11, 2004.Benazepril Hydrochloride Tablets are the AB-rated generic equivalent of Novartis' antihypertensive agent Lotensin® Tablets. Annual sales of the brand product are approximately $333 million.Teva Pharmaceuti Read More »

Thursday, November 06, 2003
Teva Announces English Court Of Appeal Upholds Lower Court Ruling To Revoke Two Fosamax® Patents

Jerusalem, Israel, November 6, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the English Court of Appeal unanimously affirmed the decision of the English Patents Court and ruled in favor of Teva and two other companies that two Merck patents, relating to Fosamax® are invalid.One of the patents relates to pharmaceuticals containing the active ingredient of Merck's Fosamax® and the second patent relates to its once weekly administration.Alendronate Sodium Tablets are the generic equivalent of Merck's Fosamax® Tablets. The product is indicated for the treatment an Read More »

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