Par poised to launch generic Dostinex
SPRING VALLEY, N.Y., Dec. 1 (UPI) -- Par Pharmaceutical said Thursday it has been tentatively cleared to market the first generic of Pfizer's Dostinex.
The Food and Drug Administration tentatively approved Par's cabergoline tablets to treat hyperprolactinemic disorders, pending expiration of Pfizer's patent Dec. 29, Par said.
U.S. sales of Dostinex exceed $80 million, the Spring Valley, N.Y.-based company said.
Dostinex was approved in 1997 to treat hyperprolactinemic disorders, either idiopathic or due to pituitary tumors.
Hyperprolactinemia is typically caused by a benign tumor on the pituitary gland that results in excess production of prolactin, the hormone that controls lactation.
Doctors treat from 70,000 to 100,000 patients with the condition each year, the vast majority of whom are women between the ages of 20 and 50. The disorder can cause cessation of menstruation, excessive milk discharge and infertility.
