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Novo Nordisk : FDA Okays Diabetes Drug Ozempic

Novo Nordisk I(NVO) said that the US Food and Drug Administration has approved Ozempic or semaglutide injection. Ozempic is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Ozempic, the approved brand name for once-weekly semaglutide in the US, is a glucagon-like peptide 1 (GLP-1) receptor agonist. The approval of Ozempic is based on the results from the SUSTAIN clinical trial programme and follows a positive recommendation from an FDA Advisory Committee meeting on 18 October 2017.

Ozempic is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and
will be launched in the Ozempic Pen, the latest generation of Novo Nordisk
prefilled devices.

Novo Nordisk noted that it will, as part of the post-approval requirements, conduct a
paediatric trial in adolescents under 18 years of age and will add Ozempic to
the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted
for all other long-acting GLP-1 products.

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