[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15577-15578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07440]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1336]
Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18
Abbreviated 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 18 abbreviated new drug applications (ANDAs)
from multiple applicants. The holders of the applications 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requested that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of May 11, 2018.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[email protected].
SUPPLEMENTARY INFORMATION: The holders of the applications 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. 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
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ANDA 040252.............. Carisoprodol and Oxford
Aspirin Tablets USP, Pharmaceuticals,
200 milligrams (mg)/ LLC, 301 Leaf Lake
325 mg. Pkwy., Birmingham,
AL 35211.
ANDA 040283.............. Carisoprodol, Aspirin, Do.
and Codeine Phosphate
Tablets USP, 200 mg/
325 mg/16 mg.
ANDA 061214.............. Tetracycline Roxane Laboratories,
Hydrochloride (HCl) Inc., 1809 Wilson
Capsules USP, 250 mg Rd., Columbus, OH
and 500 mg. 43228.
ANDA 061682.............. Tetracycline HCl Mylan Pharmaceuticals
Tablets, 500 mg. Inc., P.O. Box 4293,
Morgantown, WV
26505.
ANDA 062212.............. Totacillin (ampicillin/ GlaxoSmithKline, Five
ampicillin Moore Dr., P.O. Box
trihydrate) Capsules, 13398, Research
Equivalent to (EQ) Triangle Park, NC
250 mg base and EQ 27709.
500 mg base.
ANDA 062654.............. Rocephin (ceftriaxone Hoffman La-Roche,
sodium) for Inc., c/o Genentech,
Injection, EQ 500 mg Inc., 1 DNA Way, MS
base/vial, EQ 1 gram 241B, South San
(g) base/vial, and EQ Francisco, CA 94080.
2 g base/vial.
ANDA 062680.............. Oxacillin Sodium for ACS Dobfar S.p.A., c/
Injection (Pharmacy o Interchem Corp.,
Bulk Package). 120 Route 17 North,
Paramus, NJ 07653.
ANDA 065124.............. Cefotaxime for Lupin Ltd., c/o Lupin
Injection USP, EQ 500 Pharmaceuticals,
mg base/vial, EQ 1 g Inc., 111 South
base/vial, and EQ 2 g Calvert St.,
base/vial. Harborplace Tower,
24th Floor,
Baltimore, MD 21202.
ANDA 065263.............. Ceftriaxone for Do.
Injection USP, EQ 10
g base/vial (Pharmacy
Bulk Package).
ANDA 074845.............. Diltiazem HCl Extended- Biovail Corp.
Release Capsules USP, International,
60 mg, 90 mg, and 120 Subsidiary of
mg. Valeant
Pharmaceuticals
North America, LLC,
400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
[[Page 15578]]
ANDA 077173.............. Ondansetron Injection Sun Pharmaceutical
USP, EQ 2 mg base/ Industries Ltd., c/o
milliliter (mL). Sun Pharmaceutical
Industries, Inc., 2
Independence Way,
Princeton, NJ 08540.
ANDA 078598.............. Ciprofloxacin Amring
Ophthalmic Solution Pharmaceuticals,
USP, EQ 0.3% base. Inc., 1235 Westlakes
Dr., Suite 205,
Berwyn, PA 19312.
ANDA 078805.............. Irinotecan HCl Sun Pharma Global
Injection, 20 mg/mL. FZE, c/o Sun
Pharmaceutical
Industries, Inc., 2
Independence Way,
Princeton, NJ 08540.
ANDA 086024.............. Capital and Codeine Valeant
(acetaminophen and Pharmaceuticals
codeine phosphate) North America, LLC,
Oral Suspension USP, 400 Somerset
120 mg/12 mg per 5 mL. Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 091180.............. Dorzolamide HCl and Zambon S.p.A., c/o
Timolol Maleate Camargo
Ophthalmic Solution, Pharmaceutical
EQ 2% base/EQ 0.5% Services, LLC, 9825
base. Kenwood Rd., Suite
203, Cincinnati, OH
45242.
ANDA 203176.............. Nevirapine Tablets Technology Organized,
USP, 200 mg. LLC, 9191 Point
Replete Dr., Fort
Belvoir, VA 22060.
ANDA 204900.............. Amlodipine Besylate Sovereign
Tablets USP, EQ 2.5 Pharmaceuticals,
mg base, EQ 5 mg LLC, 7590 Sand St.,
base, and EQ 10 mg Fort Worth, TX
base. 76118.
ANDA 209480.............. Clozapine Tablets USP, Zydus Pharmaceuticals
25 mg, 50 mg, 100 mg, USA, Inc., 73 Route
and 200 mg. 31 North,
Pennington, NJ
08534.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
11, 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 May 11, 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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07440 Filed 4-10-18; 8:45 am]
BILLING CODE 4164-01-P