The FDA has given tentative approval for Ivax Corp.'s ANDA for doxazosin mesylate in 1 mg., 2 mg., 4 mg. and 8 mg. tablet strengths.
Indicated for benign prostatic hyperplasia and hypertension, doxazosin mesylate tablets are the generic equivalent of Pfizer's Cardura, which had sales of approximately $313 million in the United States in 1999.
Miami-based IVAX will market the product through its wholly-owned subsidiary, Zenith Goldilne Pharmaceuticals.
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