Phase 3
Development Phase
0
Upcoming Catalysts
0
Historical Events
2
Regulatory Approvals
No catalyst events have been recorded for this drug yet.
Somatropin Biopartners
Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.
NutropinAq
Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. Long-term treatment of growth failure associated with Turner syndrome. Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.
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