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Children and adolescents whose telomere and endocrine systems are still maturing due to a lack of safety data
For that indication, it is pretty potent and in clinical trials, can reduce the HbA1c by 1-1.5%
One of the relevant exclusivity periods applies to New Drug Applications (NDA) for approved products containing new chemical entities (NCEs), whereby an ANDA with a paragraph IV certification may not be submitted until four years after the NDA was approved (i.e., the NCE-1 date)
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