Apotex Receives Final Approval for Zonisamide Capsules.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 zonisamide capsules in 25 mg, 50 mg and 100 mg strengths. Shipments of the product will commence immediately. Apotex' zonisamide is available in 100-count bottles, and is the generic equivalent of Eisai's Zonegran(R) used to treat epilepsy. Annual sales for the brand are approximately $174 million. The Apotex Group manufactures more than 100 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. Zonegran(R) is a registered trademark of Dainnipon Pharmaceutical Co. Ltd. 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion