Andrx Corporation announced that the United States Food and Drug Administration (FDA) has issued an approvable letter for Pfizer Inc's New Drug Application (NDA) for Cardura XL, a sustained-release formulation of doxazosin mesylate, used to treat benign prostatic hyperplasia (BPH).

As previously announced, Andrx will receive exclusive distribution rights to Cardura XL in the United States upon the approval of the product with certain minimum claims. The FDA's approvable letter sets out the conditions that must be met before final marketing approval is obtained. Pfizer has responsibility for the NDA and has informed us that it intends to respond promptly to the conditions of the approvable letter.