Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that it has received final FDA approval for its Abbreviated New Drug Application for the generic version of Actonel.
Actonel, a Procter & Gamble Company (NYSE:PG) product, is used in the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis and for the treatment of Paget's disease.
Teva is currently in patent litigation concerning the generic version of Actonel. A trial was held in November 2006 but no decision has been rendered. As part of the litigation Teva agreed to give a 30 day notice to Procter and Gamble prior to any launch of the product. Notice has not yet been given.
Teva has been awarded 180 days marketing exclusivity for being the first company to file an Abbreviated New Drug Application. This exclusivity will begin from the date of commercial marketing.
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