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www.fdanews.com/articles/90822-savient-teams-up-with-watson-to-launch-generic-oxandrin

SAVIENT TEAMS UP WITH WATSON TO LAUNCH GENERIC OXANDRIN

January 9, 2007

Savient Pharmaceuticals plans to launch an authorized generic version of its own patented weight-gain drug, Oxandrin, the company announced.

Under the agreement, Savient will launch AB rated authorized generic oxandrolone tablets in 2.5- and 10-mg doses. The authorized generic product will be launched immediately and distributed by Watson Pharmaceuticals. An AB rating is normally applied to generic pharmaceutical products in which studies have demonstrated that the drug is therapeutically equivalent to the reference drug.

The announcement comes after a federal appeals court granted an eleventh-hour request made by Savient asking the court to prevent sales of generic Oxandrin by Sandoz Pharmaceuticals, a Novartis Pharmaceuticals subsidiary, and Upsher-Smith Laboratories from going forward.

Savient sought to block sales of generic oxandrolone by originally requesting a restraining order in connection with a pending patent infringement lawsuit against Sandoz and Upsher-Smith regarding about five different method-of-use patents for Oxandrin.

Savient said anticipated generic competition for its drug prompted its move to launch an authorized generic. The company will continue to market and distribute Oxandrin, the company said.

Third-quarter sales of Oxandrin in the U.S. totaled $15.9 million, the company said.