Par gets FDA approval for cabergoline, generic of Pfizer's Dostinex to treat hyperprolactinemic disorders

By E. Janene Geiss

Philadelphia, Dec. 29 - Par Pharmaceutical Cos., Inc. announced Thursday that it has received final approval from the Food and Drug Administration for the company's Abbreviated New Drug Application for cabergoline tablets.

Cabergoline is the generic version of Pfizer's Dostinex and is used for the treatment of hyperprolactinemic disorders.

Annual U.S. sales of Dostinex exceed $80 million, according to a company news release.

Par said it will begin shipping cabergoline tablets immediately.

Par develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

In 2005, Par received approval for and introduced Megace ES, its first branded pharmaceutical product, and expects to launch its second in 2006. The company manufactures, markets or licenses more than 90 generic drugs.

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