federal_register: 2024-26915
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-26915 | Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and regulatory requirements are met. | 2024-11-19 | 2024 | 11 | https://www.federalregister.gov/documents/2024/11/19/2024-26915/determination-that-jesduvroq-daprodustat-tablets-1-milligram-2-milligrams-4-milligrams-6-milligrams | https://www.govinfo.gov/content/pkg/FR-2024-11-19/pdf/2024-26915.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow... |