Somatrem

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Trade name: Protropin

Manufacturer: Genentech Inc., South San Francisco, CA

Indications: Treatment of growth hormone deficiency in children

Approval date: 17 October 1985

Type of submission: Product license application

A. General description Somatrem is a polypeptide hormone produced by DNA technology. It has 192 amino-acid residues and a molecular weight of 22kDa. Soma-trem contains the sequence of 191 amino acids constituting pituitary-derived human growth hormone plus an additional amino acid, methionine, on the N-terminus of the molecule. Somatrem is synthesized in a strain of Escherichia coli bacteria modified by the addition of the gene for human growth hormone production.

B. Indications and use Protropin is administered to children with documented lack of human growth hormone.

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