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# Adventa Nintedanib Petition Granted, Denied
- URL: https://www.fdaweb.com/adventa-nintedanib-petition-granted-denied/
- Published: 2026-03-24T12:00:00.000Z
- Updated: 2026-09-14T13:36:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160866

FDA has granted in part and denied in part an AdventaPharma 10/24/2025 petition asking the agency to take specific actions on ANDAs for nintedanib. The agency’s [response](https://downloads.regulations.gov/FDA-2025-P-5582-0003/attachment%5F1.pdf?ref=fdaweb.com) says Adventa specifically asked that FDA, before granting full approval:

- require that ANDA holders of nintedanib conduct comprehensive risk assessments of their products for nitrosamine drug substance-related impurities (NDSRIs);
- require that ANDA holders of nintedanib determine and meet acceptable intake limits for the NDSRIs relevant to the production of nintedanib;
- require that ANDA holders adhere to the three-step mitigation strategy outlined in a specific FDA guidance;
- require that ANDA holders of nintedanib establish specification limits for all identified nitrosamine impurities in drug products when confirmatory testing reveals levels exceeding 10% of the recommended acceptable intake; and
- require that ANDA holders of nintedanib appropriately implement and document to FDA their findings relating to acceptable intake limits and the results of their strict adherence to the three-step mitigation strategy.

FDA says that to the extent that the petition asks FDA to apply requirements in the Federal Food, Drug, and Cosmetic Act and its implementing regulations with respect to impurities for ANDAs for nintedanib, the petition is granted. But, it says, to the extent that it requests that FDA categorically require applicants to comply with recommendations in guidance, those requests are denied because such recommendations are not binding. Applicants may propose scientifically justified approaches that meet the applicable statutory and regulatory requirements, it says.

The agency letter says Adventa noted in its petition that FDA has granted tentative approval to six ANDAs for nintedanib capsules, citing Ofev (nintedanib esylate) capsules 100 mg and 150 mg as the reference-listed drug. Ofev is approved to treat idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases with a progressive phenotype, and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.

“Your petition expresses concern that generic nintedanib products may reach the market without adequate controls for nitrosamine impurities and requests that FDA impose specific requirements on ANDA holders for generic nintedanib prior to granting approval,” the letter says. “FDA shares your commitment to ensuring that all approved drug products meet appropriate quality standards. However, FDA’s current regulatory framework comprehensively addresses the control of nitrosamine impurities and the concerns raised in your petition…. FDA evaluates the control of nitrosamine impurities during the ordinary course of ANDA review.”