News

Jerusalem, Israel, August 14, 2001 - Teva Pharmaceutical Industries Ltd.(Nasdaq: TEVA) announced today that it has won the lawsuit brought against it by SmithKline Beecham regarding the U.S. patent covering Nabumetone, the active ingredient in Relafen®. Teva's U.S. subsidiary expects to commence sales of Nabumetone immediately. Annual sales of the branded product in the U.S. during the twelve months ended June 30, 2001, were estimated to be approximately $266 million. As the first applicant to challenge the listed patent for this drug, Teva is entitled to a 180-day period of generic marketing Read More »

Jerusalem , Israel, January 30, 2007 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' Focalin™ (Dexmethylphenidate Hydrochloride) Tablets, 2.5 mg, 5 mg, and 10 mg. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.Teva's AB-rated Dexmethylphenidate HCl Tablets are indicated for the treatment of atte Read More »

Jerusalem, Israel, March 1, 2007 - 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 Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg. Shipment of this product will begin immediately. Teva's product is the AB-rated equivalent of Pharmacia and Upjohn's Xanax® XR Tablets, a product indicated for treatment of panic disorder.Total annual sales of this product, including brand and generic sales, are approximately $54 million, based on IMS sal Read More »

Jerusalem, Israel, March 8, 2007 - 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 Cabergoline Tablets, 0.5 mg.Shipment of the product will begin immediately.Teva's Cabergoline Tablets are the AB-rated generic equivalent of Pharmacia & Upjohn's Dostinex® Tablets, a product indicated for treatment of hyperprolactinemic disorders.Total annual sales of this product in the U.S., including brand and generic sales,are approximately $74 million, based on Read More »

Jerusalem, Israel, March 11, 2007 - 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 (ANDAfor Moexipril HCland HydrochlorothiazideTablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg and 15 mg/25 mg. Shipment of these products will begin immediately.Teva's Moexipril HCl and Hydrochlorothiazide Tablets are the first AB-rated generic equivalent of Schwarz Pharma's Uniretic® Tablets, a product indicated for the treatment of hypertension.The brand product had annual sales of approx Read More »

Jerusalem, Israel, May 8, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Eli Lilly and Co's cancer treatment Gemzar® (Gemcitabine) for injection, 200 mg base/vial. Teva is currently in patent litigation concerning this product in the U.S. District Court for the Southern District of Indiana. A suit was brought against Teva in February 2006 involving Teva's paragraph IV certification to U.S. Patent Nos. 4,8 Read More »

Jerusalem, Israel, May 10, 2007 - 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 Applications (ANDA) to market its generic versions of Abbott's antibiotic Omnicef® (Cefdinir) Capsules, 300 mg, and for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL. Teva has commenced shipment of these products.Omnicef® Capsules and Omnicef® for Oral Suspension had annual sales of approximately $325 million and $533 million, respectively, in the U.S. based on IMS sales data.Teva is currently Read More »

Jerusalem, Israel, May 20, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA)announces that on May 18, 2007 the U. S. Food and Drug Administration granted to Teva final approval of its amlodipine besylate/ benazepril products in 2.5 mg/ 10 mg, 5 mg/ 10mg; 5 mg/ 20 mg and 10 mg/ 20 mg dosage strengths, AB rated to Novartis' Lotrel ® and Teva immediately commenced shipping the product. On May 19, 2007, the United States District Court for theDistrict of New Jersey granted, in connection with Novartis' pending patent infringement action,an emergency request for a temporary order restrainin Read More »

Jerusalem, Israel, June 26, 2007 - 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 Applications (ANDA) to market Ondansetron Hydrochloride Tablets, 4 mg, 8 mg and 24 mg and Ondansetron Orally Disintegrating Tablets USP, 4 mg and 8 mg. Teva has commenced shipment of these products.Teva's Ondansetron products are AB-rated generic equivalents of GlaxoSmithKline's Zofran® Tablets and Zofran® ODT, which are indicated for prevention of nausea and vomiting in patients undergoing c Read More »

Jerusalem, Israel, June 28, 2007 - 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 Famciclovir Tablets, 125 mg, 250 mg and 500 mg. Final approval of this application is anticipated on August 24, 2007, upon expiry of the mandatory stay of approval associated with patent litigation related to this application. The brand product had annual sales of approximately $190 million for the twelve months ended March 31, 2007, based on IMS sales data.Teva Pharmaceutical Industries Ltd., Read More »