Conduct Active Post Marketing Surveillance Study: CDSCO Panel tells Novo Nordisk on Somapacitan Injection
New Delhi: Granting approval for waiving off the Phase-IV study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novo Nordisk to conduct the Active Post Marketing Surveillance (PMS) study of Somapacitan Injection 5 mg/1.5 ml, 10mg/1.5ml and 15 mg/1.5 ml solution for injection in PFP.
Somapacitan is a long-acting recombinant human growth hormone derivative. Somatropin injection is used to replace growth hormone (a natural hormone produced by your body) in adults and children with growth hormone deficiency. Somatropin injection is also used to increase growth in children with certain conditions that affect normal growth and development.
Somapacitan binds to the growth hormone receptor and induces intracellular signaling to up-regulate insulin-like growth factor I (IGF-1). IGF-1 causes growth in bones and muscle tissue.
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