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a separate treatment-use formulation (0.5 mg and 1.0 mg base per vial, for treating growth hormone deficiency and growth failure in children) was approved September 26, 1997 under NDA 20-443

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Ng BG, Xu G, Chandy N, Steyermark J, Shinde DN, Radtke K, et al

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Journal of Biological Chemistry, 286 (47), 4101841027