AndroGel testosterone gel New FDA Drug Approval | CenterWatch

HomeDrug InformationFDA Approved Drugs2000 Medical Areas: Endocrinology

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The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Unimed Pharmaceuticals Approval Status: Approved February 2000 Treatment Area: For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

AndroGel is a hydroalcoholic gel to be applied to the clean, dry skin of the shoulders, upper arms and/or abdomen. The gel is absorbed through the skin and delivers testosterone to the patient for approximately 24 hours. This product is indicated for men with primary hypogonadism or hypogonadotropic hypogonadism which results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations.

Two types of hypogonadism for which this drug is indicated: 1. Primary hypogonadism: testicular failure; characterized by low serum testosterone levels and gonadotropins (FSH, LH) above the normal range

2. Hypogonadotropic hypogonadism: idiopathic gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation; characterized by low serum testosterone levels, but with gonadotropins in the normal or low range

In addition to supplying sufficient amounts of testosterone, AndroGel, like other drugs in its class, may promote retention of nitrogen, sodium, potassium, phosphorus, and decreased urinary excretion of calcium. Furthermore, it may increase protein anabolism and decrease protein catabolism. This class of drugs (androgens) may also stimulate the production of red blood cells.

Hypogonadism affects approximately 4 to 5 million American men.

Symptoms of hypogonadism include:

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AndroGel testosterone gel New FDA Drug Approval | CenterWatch

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