OZEMPIC

批准信原文要点

This Prior Approval supplemental new drug application provides for revision to the labeling information to remove the Quick Guide from the product carton for OZEMPIC (semaglutide) injection 4 mg/3 mL (1.34 mg/mL), 8 mg/3 mL (2.68 mg/mL), and 2mg/3 mL (0.68 mg/mL) dual dose (0.25 mg and 0.5 mg).

批准信原文要点

This Prior Approval sNDA provides for updates to the instructions for use (IFU) to remove statements that suggest or imply that the pen device is exclusively compatible with disposable needles made by Novo Nordisk

批准信原文要点

This Prior Approval sNDA, provides for the addition of a new presentation of Ozempic in a single dose manual prefilled syringe (mPFS) for the approved doses 0.25 mg, 0.5 mg, and 1 mg. This supplement provides for updates to the Prescribing Information (PI) , as well as a new Instructions for Use and carton and container labeling for the new single dose mPFS presentation. The supplement also provides for addition of ‘acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death’ in Section 6.2 Postmarketing Experience of the PI, for consistency with other semaglutide product labeling.

批准信原文要点

Prior Approval sNDA S-037 provides for revisions to the PI to add ‘headache’ in Section 6.2, Postmarketing Experience.

批准信原文要点

provides for the following revisions to the Prescribing Information (PI): • Revise Warnings and Precautions Section 5.2 Acute Pancreatitis and related language in Section 17 for consistency with the class. • Revise Warnings and Precautions Section 5.7 Severe Gastrointestinal Adverse Reactions to include the statement “Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.” • Add ‘intestinal obstruction, severe constipation including fecal impaction’ and ‘acute kidney injury’ in Section 6.2, Postmarketing Experience.

批准信原文要点

This Prior Approval supplemental new drug application provides for a new indication to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

批准信原文要点

This sNDA provides for revisions to the labeling for Ozempic consistent with our September 6, 2024, letter and October 11 and 16, 2024, email correspondence.

批准信原文要点

The Prior Approval sNDA, S-021, provides for the addition of ‘Gastrointestinal: Ileus’ under Section 6.3 Postmarketing Experience of the Prescribing Information (PI), and additional changes in the PI to reflect discontinuation of the 0.25/0.5 mg 2 mg/1.5 mL (1.34 mg/mL) prefilled pen presentation.

批准信原文要点

The Prior Approval sNDA, S-020, provides for revised Instructions for Use (IFU) labeling for all pen presentations.

批准信原文要点

This Prior Approval sNDA provides for a new presentation of the PDS290 pen-injector for semaglutide 0.68 mg/mL (0.25 mg/0.5 mg, 3 mL) as an addition to the already approved Ozempic presentations.

批准信原文要点

This Prior Approval sNDA provides for addition of a 3rd maintenance dose of Ozempic (2 mg subcutaneously once weekly) (2.68 mg/ml concentration).

批准信原文要点

This Prior Approval sNDA provides for the following revisions to the Prescribing Information: 1. Addition of Section 6.3 (Postmarketing Experience) to address a signal concerning hypersensitivity. This change also necessitated revisions to the Medication Guide. 2. Addition of information to Section 3 (Dosage Forms and Strengths) and Section 16 (How Supplied/Storage and Handling) pertaining to the 3 mL cartridge pen injector previously approved in supplement NDA 209637/S-001 on April 9, 2019. 3. Revisions to Section 5.5 (Hypoglycemia with Concomitant Use of Insulin Secretagoges or Insulin).

批准信原文要点

This Prior Approval supplemental new drug application provides for the addition of an indication to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease, and revised labeling to reflect the results of the SUSTAIN 6 cardiovascular outcomes trial

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Instructions for Use (IFU) documents and the carton and container labeling for the 0.25 0.5 mg and 1 mg (1.5ml) pen injector variants, in order to align the labeling, where appropriate, with the labeling that was approved under NDA 209637/S-001.

批准信原文要点

This supplement provides for updates to the Prescribing Information, as well as new Instructions for Use, and new carton and container labeling.