The US FDA granted tentative approval for Par Pharmaceutical Companies abbreviated new drug application (ANDA) for cabergoline tablets. Cabergoline is the generic version of Pfizer's Dostinex and is used for the treatment of hyperprolactinemic disorders.

Par is the first generic company to receive a tentative approval for cabergoline and expects to launch the product following expiration of US Patent No. 4,526,892 on December 29, 2005, states a company release.

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/exclusivity issues have expired.

Par Pharmaceutical Companies Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical.