2021-20511. B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA110013/0032 for 6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium Chloride Injection in EXCEL® Plastic Container, held by B. Braun Medical, Inc. B. Braun Medical, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.

DATES:

Approval is withdrawn as of October 22, 2021.

FOR FURTHER INFORMATION CONTACT:

Myrna Hanna, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240 402-7911.

SUPPLEMENTARY INFORMATION:

B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109, has requested that FDA withdraw approval of ANDA BA110013/0032, pursuant to § 314.150(c) (21 CFR 314.150(c)), because the drug is no longer being marketed. By its request, B. Braun Medical Inc. has also waived its opportunity for a hearing. Withdrawal of approval of an application under § 314.150(c) is without prejudice to refiling.

Application No.	Proprietary name
ANDA BA 110013/0032	6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection in EXCEL® Plastic Container.

Therefore, approval of the application listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of October 22, 2021. Introduction or delivery for introduction into interstate commerce for products without an approved new drug application or ANDA violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). The drug product that is listed in the table above that is in inventory on October 22, 2021 may continue to be dispensed until the inventory has been depleted or the drug product has reached its expiration date or otherwise becomes violative, whichever occurs first.

Dated: September 16, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.