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-2022-N-0030]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of March 30, 2022
 FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, 
                        *Martha.Nguyen@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. Application No.
Drug
ApplicantANDA 065408
Epirubicin Hydrochloride (HCl) Injection, 150 milligrams (mg)/75 milliliters (mL) (2 mg/mL), 10 mg/5 mL (2 mg/mL), 50 mg/25 mL (2 mg/mL), and 200 mg/100 mL (2 mg/mL)
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.ANDA 065411
Epirubicin HCl Injection, 200 mg/100 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL)
Do.ANDA 065440
Idarubicin HCl Injection, 1 mg/mL
Do.ANDA 077790
Fludarabine Phosphate for Injection, 50 mg/vial
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.ANDA 091008
Gabapentin Capsules, 100 mg, 300 mg, and 400 mg
Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, Venus Pharmaceutical Laboratories Inc., 506 Carnegie Center, Suite 100, Princeton, NJ 08540.
 
 
 Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 30, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on March 30, 2022 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: February 18, 2022. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2022-04153 Filed 2-25-22; 8:45 am] BILLING CODE 4164-01-P