Apotex Receives Final Approval for Leflunomide Tablets.WESTON, Fla. -- Apotex Corp. today announced that it has received final approval from the U.S. Food and Drug Administration (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. ) for its 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 ANDA abbr. abbreviated new drug application ) for Leflunomide Tablets in 10mg and 20mg dosage strengths. Shipments of the drug are expected to commence immediately. Leflunomide is the generic equivalent of Sanofi-Aventis' Arava(R), a rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. treatment for adults. U.S. annual sales for leflunomide tablets are approximately $228 million. "We are very pleased to add leflunomide tablets to our robust portfolio of high-quality generic pharmaceuticals," said Apotex President Tammy McIntire. "This is our 20th generic approval in the last twelve months, and with hundreds more products in development the pipeline continues to be strong," McIntire added. Apotex' leflunomide is packaged in 30-ct. bottles. The Apotex Group manufactures more than 50 different high-quality generic pharmaceuticals, used by millions of patients worldwide. Its product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics and inhalation solutions. Arava(R) is a registered trademark of Sanofi-Aventis. Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida Weston is a city located in Broward County, Florida, USA. Established as a city in 1996, much of the community was developed by Arvida/JMB Partners and is located near the western developmental boundary of Broward County. As of 2006, the city had a total population of 65,793. and operations center The facility or location on an installation, base, or facility used by the commander to command, control, and coordinate all crisis activities. See also base defense operations center; command center. in Indianapolis, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit apotexcorp.com. |
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