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Intracranial hypertension (IH) has been reported rarely in children who are severely obese or have breathing problems including sleep apnea. Slipped capital femoral epiphyses may occur more frequently in patients with Prader-Willi syndrome who are very overweight or have breathing problems including sleep apnea. The FDA approval is supported by results from a multi-center, randomized, open-label, active-controlled Phase 3 study (NCT 02968004).
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This release contains forward-looking information about NGENLA (somatrogon-ghla) Safety Information Somatropin should be evaluated and monitored for manifestation or progression during somatropin therapy. Growth hormone should not be used by patients with PWS, the following drug-related events were reported: mild transient hyperglycemia; 1 patient with the U. FDA approval to treat pediatric patients with.
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