FDAnews
www.fdanews.com/articles/91364-fda-approves-teva-s-generic-dostinex

FDA APPROVES TEVA'S GENERIC DOSTINEX

March 9, 2007

Teva Pharmaceutical Industries announced that the FDA has granted approval to its abbreviated new drug application for generic cabergoline tablets, 0.5 mg. The company said it will begin shipping the product immediately.

Teva's product is the AB-rated generic equivalent to Pharmacia & Upjohn's Dostinex, a drug indicated for treatment of hyperprolactinemia, the excess secretion of the hormone prolactin by the pituitary gland.

Total annual sales of this product in the U.S., including brand and generic sales, are approximately $74 million, according to Teva's announcement.