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Notice

Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications

A Notice by the Food and Drug Administration on 10/29/2018

Document Details

Information about this document as published in the Federal Register.

Printed version:
PDF
Publication Date:
10/29/2018
Agencies:
Food and Drug Administration
Dates:
Approval is withdrawn as of November 28, 2018.
Document Type:
Notice
Document Citation:
83 FR 54355
Page:
54355-54356 (2 pages)
Agency/Docket Number:
Docket No. FDA-2018-N-3647
Document Number:
2018-23528
Document Details
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Published Document

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of November 28, 2018.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

End Further Info End Preamble Start Supplemental Information

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 in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Start Printed Page 54356Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Application No.DrugApplicant
NDA 009165Delatestryl (testosterone enanthate) Injection, 200 milligrams (mg)/milliliter (mL)Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355.
NDA 010417Xylocaine (lidocaine hydrochloride (HCl)) 4% Topical Solution/Sterile InjectionFresenius Kabi, USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
NDA 016297Xylocaine (1.5% lidocaine HCl with dextrose 7.5%) Spinal Injection, 2 mL ampulesDo.
NDA 016724Norinyl 1+80 (mestranol and norethindrone) 21-Day Tablets, 0.08 mg/1 mgGD Searle LLC, a subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 016725Norinyl 1+80 (mestranol and norethindrone) 28-Day Tablets, 0.08 mg/1 mgDo.
NDA 019217Sodium Chloride 0.9% Injection USP in Plastic Container, 9 mg/mLICU Medical, Inc., 600 N. Field Dr., Lake Forest, IL 60045.
NDA 019222Dextrose 5% Injection USP in Plastic Container, 50 mg/mLDo.
NDA 203098Testosterone Gel, 2.5 mg/1.25 grams (g), 25 mg/2.5 g, 50 mg/5 gPerrigo Co., U.S. Agent for Perrigo Israel Pharmaceuticals Ltd., 3490 Quebec Ave. North, Minneapolis, MN 55427.
NDA 204031Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mgMallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
NDA 205777Targiniq ER (naloxone HCl and oxycodone HCl) Extended-Release Tablets, 5 mg/10 mg, 10 mg/20 mg, and 20 mg/40 mgPurdue Pharma, LP, One Stamford Forum, Stamford, CT 06901-3431.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 28, 2018. 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 November 28, 2018 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.

Start Signature

Dated: October 23, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-23528 Filed 10-26-18; 8:45 am]

BILLING CODE 4164-01-P

Published Document