MILAN, Italy, Aug. 23 /PRNewswire/ -- Eurand today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for potassium chloride 20mEq tablets. Potassium Chloride 20mEq is the generic version of Key Pharmaceutical's K-Dur 20(R) tablet, a potassium supplement used in the treatment of hypokalemia, digitalis intoxication and hypokalemic familial periodic paralysis. The U.S. market for potassium chloride 20mEq is approximately $130 million. Eurand will license the product in the United States to a marketing partner.
"Eurand's product utilizes our Microcaps(R) technology and will be our eighth product launched in the US using this innovative technology," said Gearoid Faherty, Chief Executive Officer of Eurand. "Our Microcaps technology continues to be one of Eurand's most sought after technologies due to its ability to achieve both unique controlled release profiles and excellent product taste masking."
"This product was developed by Eurand and is the first product in our internal product pipeline to be approved in the US. Our strategy is to develop and file our own products in the world's major markets, when approved these products will be marketed directly by Eurand or licensed to marketing partners. While Eurand's primary focus is on therapeutically unique products, we developed this ANDA product to support and expand our current KCl franchise," continued Mr. Faherty.
Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. The Company specializes in bioavailability enhancement of poorly soluble drugs utilizing its Biorise(R) platform, modified release and taste masking and is currently developing a pipeline of products based on its proprietary technologies. Eurand also works with many of the world's leading pharmaceutical and biotechnology companies to develop enhanced forms of their existing products and development compounds. Eurand's headquarters are located in Milan, Italy while Eurand's US operating offices are in Vandalia, Ohio. The Company has research, development and manufacturing facilities in Italy, the United States and manufacturing facilities in France. For additional company information, please visit http://www.eurand.com/
EurandCONTACT: Gearoid Faherty, CEO of Eurand, (Italy) +39-02-954281,bizdev@eurand.com
Web site: http://www.eurand.com/
