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news.Generic drug specialist Par Pharmaceutical has been granted tentative approval by the FDA to market cabergoline, a version of Pfizer's Dostinex, used to treat a hormonal disorder that can lead to infertility.
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Par is the first generic company to receive a tentative approval for the cabergoline tablets and expects to launch the product following expiration of Pfizer’s US patent on December 29, 2005.
A tentative approval reflects the FDA’s preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of any patents or exclusivity periods accorded to the reference listed drug. A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent and exclusivity issues have expired.
Dostinex is indicated for the treatment of hyperprolactinemic disorders involving excessive levels of the hormone prolactin in the blood. Too much prolactin can lead to changes in menstruation or even infertility in women. Men can also suffer from the disorder, commonly experiencing impotency as a result. According to Par, annual US sales of Dostinex presently exceed $80 million.
Par’s shares were up by 2.8% to $27.35 in early trading following the FDA decision.