83 FR 54355 - Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 209 (October 29, 2018)

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54355-54356]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3647]


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

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 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applications be withdrawn.

DATES: Approval is withdrawn as of November 28, 2018.

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.

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 Sec.  314.150(c) (21 CFR 314.150(c)). The applicants have 
also, by their requests, waived their opportunity for a hearing.

[[Page 54356]]

Withdrawal of approval of an application or abbreviated application 
under Sec.  314.150(c) is without prejudice to refiling.

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

    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.

    Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23528 Filed 10-26-18; 8:45 am]
 BILLING CODE 4164-01-P