2020-10082. Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

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 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of June 11, 2020.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, [e-mail].

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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 11, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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