Barr Laboratories, Inc., a subsidiary of
Barr Pharmaceuticals, Inc. (NYSE:
BRL) has been granted tentative approval by the USFDA for its generic version of
Roche Laboratories, Inc.'s
KYTRIL® (granisetron hydrochloride) Tablets, 1mg (base).
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 cisplatin; and, nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Barr Laboratories is expecting to receive 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.
Source: Barr Pharmaceuticals
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