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# Restrictions on Lutathera ANDA Sought
- URL: https://www.fdaweb.com/restrictions-on-lutathera-anda-sought/
- Published: 2024-04-17T12:00:00.000Z
- Updated: 2026-09-14T14:28:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156794

Novartis’ Advanced Accelerator Applications is asking FDA to impose restrictions on ANDAs or 505(b)(2) NDAs that reference and rely on Novartis’ Lutathera (lutetium Lu 177 dotatate) for approval. The [petition](https://downloads.regulations.gov/FDA-2024-P-1871-0001/attachment%5F1.pdf?ref=fdaweb.com) asks FDA to ensure that any applicants demonstrate that their product contains the same amount of the active ingredient as Lutathera, and that the active ingredient has the same strength and potency as Lutathera based on criteria that are appropriate and necessary for radioligand therapeutics, including the specific activity and total mass of ligand, in addition to volumetric activity and total activity, to show that a proposed product is pharmaceutically equivalent and can be expected to have the same clinical effect and safety profile as Lutathera when administered to patients under the conditions specified in the labeling.