federal_register: 2025-23870
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025-23870 | Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing | Notice | The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs. | 2025-12-29 | 2025 | 12 | https://www.federalregister.gov/documents/2025/12/29/2025-23870/egis-pharmaceuticals-limited-etal-proposal-to-withdraw-approval-of-three-abbreviated-new-drug | https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23870.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a... |