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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Endocrinology

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Genotropin (somatropin) lyophilized powder

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

Company: Pharmacia & Upjohn
Approval Status: Approved November 1997
Treatment Area: growth hormone deficiency

General Information

Genotropin Lyophilized Powder (somatropin rDNA origin) has been approved for the treatment of growth hormone deficiency in adults.

Clinical Results

In vitro, preclinical, and clinical studies have demonstrated that Genotropin is therapeutically equivalent to human growth hormone of pituitary origin. In six placebo-controlled clinical studies of 172 GHD adults, 85 of whom received Genotropin, lean body mass, total body water, and lean/fat ratio all increased while total body fat mass and waist circumference decreased after six months. These effects on body composition were maintained when treatment was continued beyond six months. Bone mineral density declined after six months of treatment but returned to baseline values after 12 months.

Additional Information

Growth hormone deficiency occurs when the pituitary gland does not secrete sufficient amounts of endogenous growth hormone. Adults may acquire this condition as a result of treatment of pituitary tumors, or from other medical conditions resulting in hypopituitarism; it can also be a continuation of childhood-onset growth hormone deficiency.