FDA APPROVES TEVA'S ANDA TO MARKET GENERIC VERSION OF ZOCOR.Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. (Nasdaq: TEVA), Jerusalem, Israel, has announced that the U.S. Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) to market its generic version of Merck's Zocor(R) (Simvastatin) Tablets, 5 mg, 10 mg, 20 mg, and 40 mg. Shipment of these products has commenced. Teva's AB-rated Simvastatin Tablets USP USP - unique sales point are indicated for the treatment of high cholesterol. Annual brand product sales in the U.S. of the 5 mg, 10 mg, 20 mg and 40 mg strengths were approximately $4.1 billion for the twelve months ended March 2006, based on IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data. As the first company to file an ANDA containing a paragraph IV certification for these strengths, Teva has been awarded 180 days of marketing exclusivity. Israel Makov, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Teva commented, "We are obviously pleased to receive final approval of our generic version of Zocor(R). Teva is proud to lead the largest generic launch in history. This reaffirms our commitment to offering our customers the broadest product portfolio and developing the deepest pipeline in the generic industry. The addition of generic Zocor(R) complements Teva's long term strategy for providing high-quality and low-cost drug alternatives to the American public." Today's approval follows an order by the United States District Court for the District of Columbia The United States District Court for the District of Columbia is the United States District Court that hears cases originating in the District of Columbia over which federal courts have original jurisdiction. denying Sandoz's request that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. not approve Teva's generic Zocor(R) products pending a determination of its motion for a preliminary injunction ordering the FDA to approve Sandoz's ANDA. 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 80% of Teva's sales are in North America and Europe. For more information, call 215/591-3030. |
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