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Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA 710497/0 for Anticoagulant Citrate Dextrose Solution A, USP (ACD-A), In Plastic Bags, held by Haemonetics Manufacturing, Inc. Haemonetics Manufacturing, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.

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Approval is withdrawn as of December 12, 2019.

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Sana F. Hussain, 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.

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Haemonetics Manufacturing, Inc., 400 Wood Rd., Braintree, MA 02184, has requested that FDA withdraw approval of ANDA BA 710497/0, pursuant to § 314.150(c) (21 CFR 314.150(c)), because the drug is no longer being marketed. By its request, Haemonetics Manufacturing, 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 710497/0Anticoagulant Citrate Dextrose Solution A, USP (ACD-A) In Plastic Bags.

Therefore, approval of the application listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 12, 2019. 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 December 12, 2019 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.

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Dated: October 29, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-24527 Filed 11-8-19; 8:45 am]