Document ID: FDA-2019-N-4777-0001
Agency: fda
Document Type: Notice
Title: Haemonetics Manufacturing, Inc.; Withdrawal of Approval of Abbreviated
New Drug Application of Anticoagulant Citrate Dextrose Solution A, USP
Posted Date: 2019-11-12T05:00Z

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61065-61066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24527]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4777]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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the application be withdrawn because the drug is no longer being 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.

[[Page 61066]]

DATES: Approval is withdrawn as of December 12, 2019.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: Haemonetics Manufacturing, Inc., 400 Wood 
Rd., Braintree, MA 02184, has requested that FDA withdraw approval of 
ANDA BA 710497/0, pursuant to Sec.  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 Sec.  
314.150(c) is without prejudice to refiling.

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              Application No.                     Proprietary name
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ANDA BA 710497/0..........................  Anticoagulant Citrate
                                             Dextrose Solution A, USP
                                             (ACD-A) In Plastic Bags.
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    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.

    Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24527 Filed 11-8-19; 8:45 am]
 BILLING CODE 4164-01-P