New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting approval to Novo Nordisk India for its proposed update to the package insert of Semaglutide Injection (Wegovy and Wegovy FlexTouch), specifically revisions to Section 4.8, Undesirable Effects and Section 5.2, Pharmacodynamic Properties.

This came after the The firm presented the proposal for an update in Package Insert for the drug product Semaglutide Injection 0.25 mg/ 0.5 mg mg/1.7 mg/2.4 mg [Brand name: Wegovy (Single-dose Pen injector)] and Semaglutide Injection 0.25 mg/0.5 mg/1 mg/1.7 mg/2.4 mg [Brand Name: Wegovy FlexTouch] to include updates in Section 4.8—Undesirable effects and Section 5.2—Pharmacodynamic properties based on the results of the cond

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