Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-1138]</DEPDOC> <SUBJECT>Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or Agency) is withdrawing approval of two new drug applications (NDAs) from two 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Approval is withdrawn as of June 30, 2025. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Jennifer Scharpf, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 240-402-8437. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process 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 under § 314.150(c) is without prejudice to refiling. <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,r100,r100"> <TTITLE>Table 1—NDAs for Which Approval Is Withdrawn</TTITLE> <CHED H="1">Application No.</CHED> <CHED H="1">Drug</CHED> <CHED H="1">Applicant</CHED> <ROW> <ENT I="01">NDA 830715</ENT> <ENT>Promit (dextran1), 150 mg/mL</ENT> <ENT>Meda AB, C/O Mylan Specialty L.P., 3711 Collins Ferry Rd., Morgantown, WV 26505.</ENT> </ROW> <ROW> <ENT I="01">NDA 890105</ENT> <ENT>Hespan (6% hetastarch in 0.9% sodium chloride injection) in Excel Plastic Container</ENT> <ENT>B. Braun Medical, Inc., 824 12th Ave., PA 18018.</ENT> </ROW> </GPOTABLE> Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of June 30, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on June 30, 2025 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. <SIG> <DATED>Dated: May 23, 2025.</DATED> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-09781 Filed 5-29-25; 8:45 am]</FRDOC> </NOTICE>