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Home Industry News Teva receives FDA approval for generic Actonel

Teva receives FDA approval for generic Actonel

10th October 2007

Teva Pharmaceutical Industries has been granted final approval to market its generic version of Procter and Gamble’s Actonel (risedronate sodium) tablets.

The US Food and Drug Administration granted final approval for the company’s Abbreviated New Drug Application (Anda) to market Actonel tablets of 5mg, 30mg and 35mg.

The tablets are indicated for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis as well as for treatment of Paget’s disease.

With the company being the first to file an Anda with a paragraph IV patent certificate, Teva has been awarded with 180 days marketing exclusivity for the product.

Actonel has seen annual sales of around $1 billion (500 million pounds) in the United States for the twelve months ending June 30, 2007, based on IMS sales data.

Last month, moves by Wyeth and its business partner Nycomed to take out a preliminary injunction against Teva Pharmaceuticals and Sun Pharmaceuticals was rejected by the United States District Court for the District of New Jersey.

Wyeth had attempted to block the launch of a generic version of Protonix by Teva before the expiry date of its patent of July 2010 but the court determined that Teva had been able to have sufficiently questioned the validity of the patent.

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