[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54355-54356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23528]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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applications be withdrawn.
DATES: Approval is withdrawn as of November 28, 2018.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.
------------------------------------------------------------------------
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