Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2021-N-1037] AGENCY: Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs. DATES: Approval is withdrawn as of November 22, 2021. FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-4718, James.Hanratty@fda.hhs.gov . SUPPLEMENTARY INFORMATION: The holders of an approved application to market a new drug for human use are required to submit annual reports to FDA concerning their approved application in accordance with §§ 314.81 and 314.98 ( 21 CFR 314.81 and 314.98 ). In the Federal Register of January 9, 2020 ( 85 FR 1160 ), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of 249 ANDAs because the holders of those ANDAs had repeatedly failed to submit the required annual reports for those ANDAs (“Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing”). [ 1 ] The holder of AN…
Other Federal Register documents from the same docket.
Citation: 86 FR 58675
