Barr Labs Says FDA Rejects New Cenestin Dosage

The Food and Drug Administration rejected an application submitted by Barr Laboratories (BRL) 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.

Barr said it will seek a meeting with the FDA as soon as possible to discuss the application and determine what additional action the company will take.

While Cenestin is already approved to treat symptoms associated with menopause at dose levels 0.625 mg, 1.25 mg and 0.9 mg, the company had applied to market a 0.45 mg dose. It also sells a lower dose version of the drug.

Following a study conducted by the Women's Health Initiative demonstrating that some hormone therapies increase the risk of heart attack, stroke, breast cancer and deep vein thrombosis, the health care industry recommended that women keep dosage levels of hormone therapy drugs to a minimum. Barr said the FDA's rejection won't affect the marketing of its current products.

Shares of Barr Laboratories were down $1.12, or 2%, to $52.18 in afternoon trading.

>To order reprints of this article, click here: Reprints