[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35170-35172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14288]
[[Page 35170]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0662]
Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-
Six Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 86 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that the approval of the applications be withdrawn.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: Effective Date: July 21, 2014.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document 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.
Table 1
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Application No. Drug Applicant
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ANDA 065395................. Cefazolin for Aurobindo Pharma
Injection USP, 500 Ltd., c/o
milligrams (mg) and AuroMedics Pharma
1 gram (g). LLC, 6 Wheeling Rd.
Dayton, NJ 08810.
ANDA 065481................. Ceftazidime for Do.
Injection USP, 500
mg, 1 g, and 2 g.
ANDA 065482................. Ceftazidime for Do.
Injection USP, 6 g.
ANDA 065504................. Ceftriaxone for Do.
Injection USP, 10 g.
ANDA 065505................. Ceftriaxime for Do.
Injection, 250 mg,
500 mg, 1 g, and 2
g.
ANDA 065516................. Cefotaxime for Do.
Injection USP, 10 g.
ANDA 065517................. Cefotaxime for Do.
Injection USP.
ANDA 077467................. Nateglinide Tablets, Teva Pharmaceuticals
60 mg and 120 mg. USA, 1090 Horsham
Rd., P.O. Box 1090,
North Wales, PA
19454.
ANDA 077472................. Cetirizine Ranbaxy Laboratories
Hydrochloride (HCl) Limited, c/o
Syrup, 5 mg/5 Ranbaxy Inc., 600
milliliters (mL). College Rd. East,
Princeton, NJ
08540.
ANDA 077540................. Zolpidem Tartrate Synthon
Tablets, 5 mg and Pharmaceuticals,
10 mg. Inc., 9000
Development Dr.,
P.O. Box 110487,
Research Triangle
Park, NC 27709.
ANDA 077717................. Ondansetron Orally Nesher
Disintegrating Pharmaceuticals
Tablets USP, 4 mg (USA) LLC, 13910
and 8 mg. St. Charles Rock
Rd., Bridgeton, MO
63044.
ANDA 077730................. Pravastatin Sodium Pliva HRVATSKA, c/o
Tablets, 10 mg, 20 Barr Laboratories,
mg, 30 mg, 40 mg, Inc., 400 Chestnut
and 80 mg. Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 077826................. Fenoldopam Mesylate Teva Parenteral
Injection USP, 10 Medicines, Inc., 19
mg (base)/mL. Hughes, Irvine, CA
92618.
ANDA 077888................. Ciprofloxacin Baxter Healthcare
Injection USP, 2 mg/ Corp., 1620
mL. Waukegan Rd., McGaw
Park, IL 60085.
ANDA 077905................. Topiramate Tablets, Pliva HRVATSKA, c/o
25 mg, 50 mg, 100 Barr Laboratories,
mg, and 200 mg. Inc.
ANDA 078016................. Zolpidem Tartrate Mylan
Tablets, 5 mg and Pharmaceuticals,
10 mg. Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown,
WV 26505-4310.
ANDA 078053................. Sertraline HCl Oral Ranbaxy Laboratories
Concentrate, 20 mg/ Limited, c/o
mL. Ranbaxy Inc.
ANDA 078114................. Ciprofloxacin Bedford
Injection USP in 5% Laboratories, 300
Dextrose, 2 mg/mL. Northfield Rd.,
Bedford, OH 44146.
ANDA 078132................. Ibuprofen Tablets Quality Regulatory
USP, 400 mg, 600 Consultants, U.S.
mg, and 800 mg. Agent for Northstar
Healthcare
Holdings, 501 Ivy
Lake Dr., Forest,
VA 24551.
ANDA 078187................. Risperidone Tablets Synthon
USP, 0.25 mg, 0.5 Pharmaceuticals,
mg, 1 mg, 2 mg, 3 Inc.
mg, and 4 mg.
ANDA 078322................. Anastrozole Tablets, Do.
1 mg.
ANDA 078448................. Ranitidine HCl Ranbaxy Inc., U.S.
Solution, 15 mg/mL. Agaent for Ranbaxy
Laboratories
Limited.
ANDA 078606................. Mitoxantrone Washington Food and
Injection USP. Drug Consultants,
U.S. Agent for
Fresenius Kabi
Oncology Plc., 3631
Martins Dairy
Circle, Olney, MD
20832.
ANDA 080043................. Nitrofurantoin Sandoz Inc., 2555 W.
Tablets, 50 mg and Midway Blvd.,
100 mg. Broomfield, CO
80038-0446.
ANDA 080203................. Potassium Chloride Baxter Healthcare
Injection USP, 2 Corp., 25212 W. IL
milliequivalents/mL. Route 120, Round
Lake, IL 70073.
ANDA 080642................. Hydrocortisone Sandoz Inc.
Tablets, 20 mg.
ANDA 081142................. Aminophylline Teva Parenteral
Injection USP, 25 Medicines, Inc.
mg/mL.
ANDA 081169................. Glycopyrrolate Do.
Injection USP, 0.2
mg/mL.
ANDA 081266................. Methyprednisolone Do.
Sodium Succinate
for Injection USP,
125 mg.
[[Page 35171]]
ANDA 081267................. Methylprednisolone Do.
Sodium Succinate
for Injection USP,
500 mg.
ANDA 081268................. Methyprednisolone Do.
Sodium Succinate
for Injection USP,
1 g.
ANDA 081278................. Leucovorin Calcium Do.
for Injection, 50
mg/vial.
ANDA 083254................. Halothane USP....... Hospira, Inc., 275
North Field Dr.,
Lake Forest, IL
60045.
ANDA 083263................. Alcohol in Dextrose Do.
Injection USP, 5%/
5%.
ANDA 083306................. Niacin Tablets, 50 Sandoz Inc.
mg.
ANDA 083486................. Isoproterenol HCl Baxter Healthcare
Injection USP, 0.2 Corp.
mg/mL.
ANDA 084051................. Dextroamphetamine Shire Development
Sulfate Tablets Inc., 725
USP, 5 mg and 10 mg. Chesterbrook Blvd.,
Wayne, PA 19087.
ANDA 084233................. Promethazine HCl Sandoz Inc.
Tablets, 12.5 mg.
ANDA 084472................. Folic Acid Capsules, Do.
1 mg.
ANDA 084827................. Hydrochlorothiazide Do.
and Reserpine
Tablets, 25 mg/
0.125 mg.
ANDA 085034................. Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 085133................. Imipramine HCl Do.
Tablets, 50 mg.
ANDA 085200................. Imipramine HCl Do.
Tablets, 10 mg.
ANDA 085213................. Hydrochlorothiazide Do.
and Reserpine
Tablets, 50 mg/
0.125 mg.
ANDA 085302................. Estrogens, Do.
Esterified Tablets,
1.25 mg.
ANDA 085362................. Novocaine (procaine Hospira, Inc.
HCl Injection USP).
ANDA 085370................. Dextroamphetamine Sandoz Inc.
Sulfate Tablets, 5
mg.
ANDA 085371................. Dextroamphetamine Do.
Sulfate Tablets, 10
mg.
ANDA 085402................. Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 085601................. Triamcinolone Do.
Tablets, 4 mg.
ANDA 085633................. Phendimetrazine Do.
Tartrate Capsules,
35 mg.
ANDA 085671................. Phentermine HCl Do.
Tablets, 8 mg.
ANDA 085689................. Phentermine HCl Do.
Tablets USP, 8 mg.
ANDA 085694................. Phendimetrazine Do.
Tartrate Capsules,
35 mg.
ANDA 085702................. Phendimetrazine Do.
Tartrate Capsules,
35 mg.
ANDA 085830................. Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 085852................. A-Methapred Hospira, Inc.
(methylprednisolone
sodium succinate
for injection USP),
1,000 mg/vial.
ANDA 085853................. A-Methapred Do.
(methylprednisolone
sodium succinate
for injection USP),
40 mg/vial.
ANDA 085854................. A-Methapred Do.
(methylprednisolone
sodium succinate
for injection USP),
500 mg/vial.
ANDA 085929................. A-Hydrocort Hospira, Inc.
(hydrocortisone
sodium succinate
for injection USP),
100 mg/vial.
ANDA 085930................. A-Hydrocort Do.
(hydrocortisone
sodium succinate
for injection USP),
250 mg/vial.
ANDA 085931................. A-Hydrocort Do.
(hydrocortisone
sodium succinate
for injection USP),
500 mg/vial.
ANDA 085932................. A-Hydrocort Do.
(hydrocortisone
sodium for
injection USP),
1,000 mg/val.
ANDA 086370................. Phendimetrazine Sandoz Inc.
Tartrate Tablets,
35 mg.
ANDA 086589................. Barbidonna Tablets Meda
(phenobarbital, Pharmaceuticals,
hyoscyamine Meda
sulfate, Pharmaceuticals,
scopolamine Inc., 265 Davidson
hydrobromide, and Ave., Suite 300,
atropine sulfate). Somerset, NJ 08873-
4120.
ANDA 086590................. Barbidonna Elixir Do.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate,
scopolamine
hydrobromide).
ANDA 086664................. Butibel Elixir Do.
(sodium
butabarbital and
belladonna
extract), 15 mg/5
mL and 15 mg/5 mL.
ANDA 087208................. Phentermine HCl Sandoz Inc.
Capsules, 30 mg.
ANDA 087223................. Phentermine HCl Do.
Capsules, 30 mg.
ANDA 087759................. Prochlorperazine Baxter Healthcare
Edisylate Injection Corp.
USP.
ANDA 087572................. Barbidonna No. 2 Meda
Tablets Pharmaceuticals.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate, and
scopolamine
hydrobromide) 32
mg, 0.1286 mg,
0.025 mg, and
0.0074 mg.
ANDA 088099................. Heparin Lock Flush Hospira, Inc.
Solution USP, 2,500
units/Ml.
ANDA 088175................. Chlorpropamide Par Pharmaceutical,
Tablets, 100 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 088176................. Chlorpropamide Do.
Tablets, 250 mg.
ANDA 088184................. Hydroxyzine HCl Fresenius Kabi USA,
Injection USP, 25 LLC, Three
mg/mL. Corporate Dr., Lake
Zurich, IL 60047.
ANDA 088185................. Hydroxyzine HCl Do.
Injection USP, 50
mg/mL.
ANDA 088330................. 1.5% Lidocain HCl Hospira, Inc.
Injection USP.
ANDA 089158................. Methotrexate Pharmachemie B.V., c/
Injection USP, 25 o Teva Parenteral
mg/mL. Medicines, Inc., 19
Hughes, Irvine, CA
92618.
[[Page 35172]]
ANDA 089420................. Azdone Tablets Schwarz Pharma,
(hydrocodone Inc., c/o UCB,
bitartrate 5 mg and Inc., 1950 Lake
aspirin 500 mg). Park Dr., Smyrna,
GA 30080.
ANDA 090183................. Cetirizine HCl Ranbaxy Laboratories
Syrup, 5 mg/5mL. Limited, c/o
Ranbaxy Inc.
ANDA 090196................. Letrozole Tablets Synthon
USP, 2.5 mg. Pharmaceuticals,
Inc.
ANDA 090464................. Mycophenolate Dr. Reddy's
Mofetil Tablets, Laboratories
500 mg. Limited, c/o Dr.
Reddy's
Laboratories, Inc.,
200 Somerset
Corporate Blvd.,
7th Floor,
Bridgewater, NJ
08807.
ANDA 090567................. Polyethylene Glycol Paddock
3350 Powder for Laboratories, LLC,
Oral Solution. a Perrigo Co., 3940
Quebec Ave. North,
Minneapolis, MN
55427.
ANDA 090712................. Polyethylene Glycol Do.
3350 and
Electrolytes for
Oral Solution.
ANDA 090769................. Clenz-Lyte Do.
(polyethylene glyol
3350 and
electrolytes for
oral solution).
ANDA 091315................. Mycophenolalte Dr. Reddy's
Mofetil Capsules Laboratories
USP, 250 mg. Limited, c/o Dr.
Reddy's
Laboratories, Inc.
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Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective July 21, 2014. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that
are in inventory on the date that this notice becomes effective (see
the DATES section) 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: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14288 Filed 6-18-14; 8:45 am]
BILLING CODE 4164-01-P