News

Jerusalem, Israel, January 3, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the Israeli Ministry Of Health has issued a marketing authorization for Azilect® (rasagiline) for the treatment of Parkinson's disease both as initial monotherapy in patients with early PD and as adjunct treatment in moderate-to-advanced disease. Following the receipt of this license, Azilect® will be launched in Israel in March 2005."We are extremely pleased to have received the first approval for the marketing of Azilect® here in Israel where the product originated and was develo Read More »

Jerusalem, Israel, January 14, 2005 - 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 Fluconazole Injection, 2 mg/mL in 200 mg and 400 mg bags. A launch date has not yet been finalized.Fluconazole is the generic equivalent of Pfizer's antifungal agent Diflucan®. Total annual sales of this configuration of Fluconazole Injection, including brand and generic sales, are approximately $167 million.Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmac Read More »

Annual Sales Increased 30% To Record $936 Million Jerusalem, Israel, January 26, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today, in conjunction with the release of the Sanofi-Aventis group's financial results, that global in-market sales of Copaxone® reached $261 million in the fourth quarter ended December 31, 2004, an increase of 26% over the comparable quarter of 2003. For the full year 2004, global in-market sales of Copaxone® reached an all-time high of $936 million, an increase of 30% over 2003.U.S. sales in the fourth quarter 2004 increased 23% over the fourt Read More »

Jerusalem, Israel, January 26, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Levofloxacin Tablets, 750 mg. Teva's Levofloxacin Tablets are the AB-rated generic equivalent of Ortho McNeil Pharmaceutical Inc.'s broad spectrum antibiotic Levaquin® Tablets.As the first ANDA applicant to file an ANDA with a paragraph IV patent certification, Teva has been awarded 180 days of generic drug exclusivity for Levofloxacin Tablets, 750 mg. Shipment of this product will not commence Read More »

Jerusalem, Israel, January 28, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the company's ANDA for Glyburide and Metformin HCl Tablets, 1.25 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg. Shipment of this product is expected to begin shortly.Teva's Glyburide and Metformin HCl Tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucovance® Tablets, a product indicated as an adjunct to diet and exercise in the treatment of type 2 diabetes.Teva Pharmaceutical Industries Ltd., headqu Read More »

Jerusalem, Israel, January 28, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the United States Court of Appeals for the Federal Circuit has found that U.S. Patent No. 5,994,329 is invalid and, accordingly, has reversed and vacated an August 2003 ruling by the U.S. District Court in Wilmington, Delaware which had upheld the validity of the patent. The patent is listed in the U.S. Food and Drug Admnistration's Orange Book for Merck & Co.'s Fosamax®, 35 mg and 70 mg, for which Teva has filed an Abbreviated New Drug Application to market a generic version of Fo Read More »

Conference Call Scheduled For 9:00 Am Est Jerusalem, Israel, February 2, 2005 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it will release its 2004 financial results on Tuesday, February 15, 2005, early in the morning (EST). The earnings release will be available on Teva's web site at www.tevapharm.com.Teva will host a conference call and live webcast on that same day, at 09:00AM EST to discuss its 2004 results and overall business environment. A Question & Answer session will follow this discussion. Investors and other interested parties may access a live web Read More »

Jerusalem, Israel, February 10, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Amoxicillin and Clavulanate Potassium Chewable Tablets USP, 200 mg/28.5 mg and 400 mg/57 mg. Shipment of this product is expected to begin immediately.Teva's Amoxicillin and Clavulanate Potassium Chewable Tablets are the AB-rated generic equivalent of GlaxoSmithKline's broad-spectrum antibiotic Augmentin® Chewable Tablets. Total annual sales of this product, including brand and generic sales, a Read More »

Jerusalem, Israel, February 11, 2005 - Teva Pharmaceuticals Industries Ltd. (Nasdaq: TEVA) and Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) have announced the U.S. launch of TEV-TROPIN™ (somatropin [rDNA origin] for injection), a growth hormone product for the treatment of children with short stature due to growth hormone deficiency. This product was clinically tested and FDA-approved for growth hormone deficiency (GHD), and is manufactured by Savient using recombinant DNA (rDNA) technology. Teva has begun offering TEV-TROPIN™ to pediatric endocrinologists through its fully owned GATE Pharmaceu Read More »

Jerusalem, Israel, February 13, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDAs for Levofloxacin Injection, 5 mg/mL in 250 mg/bag and 500 mg/bag (5% dextrose bags) and Levofloxacin Injection, 25 mg/mL in 20 mL and 30 mL vials. Final approval is subject to the resolution of ongoing patent litigation.Teva's Levofloxacin Injection is the AP-rated generic equivalent of Ortho McNeil's broad-spectrum antibacterial agent Levaquin® Injection.Total annual sales of the brand produc Read More »