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Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2020-N-1081]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven abbreviated new drug applications (ANDAs) from multiple applicants. The ( printed page 28017) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of June 11, 2020.

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, .

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 Applicant
ANDA 065232 Ceftriaxone Sodium for Injection, Equivalent to (EQ) 10 grams (g) base/vial Hospira Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045.
ANDA 088697 Amitriptyline Hydrochloride (HCl) Tablets, 10 milligrams (mg) Par Pharmaceutical Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 088698 Amitriptyline HCl Tablets, 25 mg Par Pharmaceutical Inc.
ANDA 088699 Amitriptyline HCl Tablets, 50 mg Do.
ANDA 088700 Amitriptyline HCl Tablets, 75 mg Do.
ANDA 088701 Amitriptyline HCl Tablets, 100 mg Do.
ANDA 088702 Amitriptyline HCl Tablets, 150 mg Do.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 11, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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 June 11, 2020, 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: May 6, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

[FR Doc. 2020-10082 Filed 5-11-20; 8:45 am]

BILLING CODE 4164-01-P

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85 FR 28016

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“Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications,” thefederalregister.org (May 12, 2020), https://thefederalregister.org/documents/2020-10082/hospira-inc-et-al-withdrawal-of-approval-of-seven-abbreviated-new-drug-applications.