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Editor's Correspondence
January 22, 2007

Estratest Is Not Approved by the Food and Drug Administration

Arch Intern Med. 2007;167(2):205-206. doi:10.1001/archinte.167.2.205-c

In the article by Tamimi and colleagues,1 published in the July 24th issue of the ARCHIVES, the authors state, “To date, the only orally active testosterone preparation in the United States approved by the FDA [Food and Drug Administration] for the indication of menopausal symptoms is a fixed combination of methyltestosterone and esterified estradiol.”1(p1483-1484) The FDA has never approved Estratest (the combination product of methyltestosterone and esterified estradiol; Solvay Pharmaceuticals, Brussels, Belgium), for any indication, even its labeled indications. Solvay Pharmaceuticals states on the package insert for Estratest, “This product has not obtained FDA pre-market approval applicable for new drugs.”2 In 1981, Solvay Pharmaceuticals submitted an Abbreviated New Drug Application for Estratest; however, this application is still pending with the FDA—25 years later. Estratest has never been FDA approved.

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