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Medical Patent Law Weekly

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Nausea Therapy



Barr receives tentative approval for generic Kytril tablets



February 14th, 2007

Barr Pharmaceuticals, Inc., (BRL) announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories, Inc.'s Kytril (granisetron hydrochloride) Tablets, 1mg (base). The company anticipates receiving final approval following the expiration of Roche's patent on December 29, 2007, or on June 29, 2008 if Roche seeks and is granted pediatric exclusivity.

Kytril (granisetron hydrochloride) Tablets, 1mg (base) is indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose...


Source: Medical Patent Law Weekly (2007-02-14)

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