Barr Labs Says FDA Rejects New Cenestin Dosage

The Food and Drug Administration rejected an application submitted by Barr Laboratories (BRL Quote) seeking approval to market a new dosage of Cenestin, an estrogen therapy drug, according to a statement released by the company on Tuesday.

The FDA determined that the application contained insufficient information for approval at this time, according to a press release.

"While we are disappointed with the FDA's action, we are committed to offering American women a full line of plant-derived synthetic conjugated estrogen products as they make important decisions regarding estrogen therapy," said Bruce L. Downey, Barr's chairman and chief executive. ...