[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16039-16042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6591]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0190]
Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug
Applications and 64 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 35 new drug applications (NDAs) and 64 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be withdrawn.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: April 18, 2012.
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
[[Page 16040]]
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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NDA 005545.................. Dicumarol Tablets... Abbott Laboratories,
PA77/Bldg. AP30-1E,
200 Abbott Park
Rd., Abbott Park,
IL 60064-6157.
NDA 005845.................. Benadryl McNeil Consumer
(diphenhydramine Healthcare,
hydrochloride Division of McNeil-
(HCl)), Benadryl PPC, Inc., 7050
with Ephedrine Camp Hill Rd., Fort
Sulfate, and Washington, PA
Caladryl 19034-2299.
(diphenhydramine
HCl and calamine).
NDA 006146.................. Benadryl Do.
(diphenhydramine
HCl)) Injection.
NDA 006773.................. Artane Lederle
(trihexyphenidyl Laboratories, d/b/a
HCl) Tablets and Wyeth
Capsules and Artane Pharmaceuticals,
(trihexyphenidyl) P.O. Box 8299,
Elixir. Philadelphia, PA
19101-8299.
NDA 009486.................. Benadryl McNeil Consumer
(diphenhydramine Healthcare.
HCl)) Injection
Preservative Free.
NDA 010021.................. Placidyl Abbott Laboratories,
(ethchlorvynol) 200 Abbott Park
Capsules. Rd., Abbott Park,
IL 60064.
NDA 011552.................. Stelazine GlaxoSmithKline,
(trifluoperazine P.O. Box 13398,
HCl). Five Moore Dr.,
Research Triangle
Park, NC 27709-
3398.
NDA 012524.................. Enduron Abbott Laboratories,
(methyclothiazide) PA77/Bldg. AP30-1E,
Tablets, 2.5 200 Abbott Park
milligrams (mg) and Rd., Abbott Park,
5 mg. IL 60064-6157.
NDA 012775.................. Enduronyl and Do.
Enduronyl Forte
(methyclothiazide
and deserpidine)
Tablets.
NDA 014684.................. Aventyl Eli Lilly and Co.,
(nortriptyline HCl) Lilly Corp. Center,
Capsules. Indianapolis, IN
46285.
NDA 017577.................. Ditropan (oxybutynin Janssen
chloride) Tablets. Pharmaceuticals
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research and
Development, LLC,
920 Route 202, P.O.
Box 300, Raritan,
NJ 08869.
NDA 018473.................. Ventolin (albuterol) GlaxoSmithKline.
Inhalation
Aerosol\1\.
NDA 018557.................. Fansidar Hoffman-La Roche,
(sulfadoxine and Inc., 340 Kingsland
pyrimethamine) St., Nutley, NJ
Tablets, 500 mg and 07110-1199.
25 mg.
NDA 018709.................. Capozide (captopril Bristol-Myers Squibb
and Co., P.O. Box 4000,
hydrochlorothiazide Princeton, NJ 08543-
) Tablets. 4000.
NDA 018814.................. Heparin Sodium in 5% Baxter Healthcare
Dextrose Injection. Corp., 1620
Waukegan Rd., MPGR-
AL, McGaw Park, IL
60085.
NDA 019297.................. Novantrone EMD Serono, One
(mitoxantrone HCl) Technology Place,
Injection. Rockland, MA 02370.
NDA 019508.................. Axid (nizatidine) SmithKline Beecham
Capsules. Corp., d/b/a
GlaxoSmithKline,
P.O. Box 13398,
Five Moore Dr.,
Research Triangle
Park, NC 27709-
3398.
NDA 019915.................. Monopril (fosinopril Bristol-Myers Squibb
sodium) Tablets, 10 Co.
mg, 20 mg, and 40
mg.
NDA 019946.................. Nuromax (doxacurium Abbott Laboratories,
chloride) Injection P76/Bldg. AP30-1E,
1 mg/milliliter Abbott Park, IL
(mL). 60064-6157.
NDA 019960.................. Manoplax Do.
(flosequinan)
Tablets.
NDA 020057.................. Ceredase Genzyme Corp., 500
(alglucerase) Kendall St.,
Injection. Cambridge, MA
02142.
NDA 020088.................. Norplant System Wyeth
(levonorgestrel) Pharmaceuticals,
Implants. Inc., P.O. Box
8299, Philadelphia,
PA 19101-8299.
NDA 020101.................. Prozac (fluoxetine Eli Lilly and Co.
HCl) Oral Solution,
20 mg/5 mL.
NDA 020236.................. Serevent (salmeterol GlaxoSmithKline.
xinafoate)
Inhalation
Aerosol\1\.
NDA 020286.................. Monopril-HCT Bristol-Myers Squibb
(fosinopril sodium Co.
and
hydrochlorothiazide
) Tablets, 20 mg/
12.5 mg and 10 mg/
12.5 mg.
NDA 020403.................. Zofran (ondansetron Glaxo Wellcome
HCl) Injection. Manufacturing Pte
Limited, d/b/a
GlaxoSmithKline,
1250 Collegeville
Rd., UP4110,
Collegeville, PA
19426.
NDA 020627.................. Norplant II System Wyeth
(levonorgestrel) Pharmaceuticals,
Implants. Inc.
NDA 020828.................. Fortovase Hoffman-La Roche,
(saquinavir) Inc.
Capsules, 200 mg.
NDA 020860.................. Levlite (ethinyl Bayer HealthCare
estradiol and Pharmaceuticals
levonorgestrel) Inc., P.O. Box
Tablets. 1000, Montville, NJ
07045.
NDA 020984.................. Raplon (rapacuronium Organon USA Inc.,
bromide) for 2000 Galloping Hill
Injection. Rd., Kenilworth, NJ
07033.
NDA 021120.................. Novantrone EMD Serono.
(mitoxantrone HCl)
Injection.
NDA 021793.................. Reglan ODT Meda Pharmaceuticals
(metoclopramide) Inc., 200 North
Tablets. Cobb Parkway, Suite
428, Marietta, GA
30062.
ANDA 040207................. Prochlorperazine Duramed
Maleate Tablets Pharmaceuticals,
USP, 5 mg and 10 mg. Inc., 400 Chestnut
Rd., Woodcliff
Lake, NJ 07677.
ANDA 040231................. Chlorpromazine HCl Pharmaceutical
Oral Concentrate Associates, Inc.,
USP, 30 mg/mL. 201 Delaware St.,
Greenville, SC
29605.
NDA 050526.................. Staticin Bristol-Myers Squibb
(erythromycin) Co.
Topical Solution,
1.5%.
[[Page 16041]]
NDA 050687.................. Banan (cefpodoxime Daiichi Sankyo,
proxetil) Tablets, Inc., 399 Thornall
100 mg and 200 mg. St., 11th Floor,
Edison, NJ 08837.
NDA 050688.................. Banan (cefpodoxime Do.
proxetil) Granules
for Oral
Suspension, 50 mg/5
mL and 100 mg/5 mL.
ANDA 064098................. Amikacin Sulfate Hospira, Inc., 275
Injection USP, 250 North Field Dr.,
mg (base)/mL. Bldg. H2-2, Lake
Forest, IL 60045.
ANDA 064106................. Mitomycin for Do.
Injection USP, 20
mg Vial.
ANDA 070505................. Metoclopramide Do.
Injection USP, 5 mg/
mL.
ANDA 070506................. Metoclopramide Do.
Injection USP, 5 mg/
mL.
ANDA 070566................. Nitropress (sodium Do.
nitroprusside for
Injection USP), 50
mg.
ANDA 071015................. Haloperidol Oral Teva Pharmaceuticals
Solution USP, 2 mg/ USA, 1090 Horsham
mL. Rd., P.O. Box 1090,
North Wales, PA
19454.
ANDA 071554................. Thiothixene HCl Oral Do.
Solution USP, 5 mg/
mL.
ANDA 073058................. Fluphenazine HCl Do.
Oral Solution USP,
5 mg/mL.
ANDA 073479................. Pentamidine Hospira, Inc.
Isethionate for
Injection, 300 mg
Vial.
ANDA 074636................. Iopamidol Injection Do.
USP, 41%, 51%, 61%,
76%.
ANDA 074898................. Iopamidol Injection Do.
USP, 41%, 51%, 61%,
76%.
ANDA 075065................. Acyclovir Sodium for Do.
Injection.
ANDA 075176................. Haloperidol Do.
Decanoate
Injection, 50 mg/mL
and 100 mg/mL.
ANDA 075409................. Midazolam HCl Do.
Injection, 1 mg
(base)/mL and 5 mg
(base)/mL.
ANDA 075884................. Milrinone Lactate Do.
Injection, 1 mg/mL.
ANDA 076306................. Topiramate Tablets, Roxane Laboratories,
25 mg, 50 mg, 100 Inc., 1809 Wilson
mg, and 200 mg. Rd., Columbus, OH
43228.
ANDA 077138................. Ciprofloxacin Teva Pharmaceuticals
Injection USP in 5% USA.
Dextrose Injection.
ANDA 077223................. Terbinafine HCl Roxane Laboratories,
Tablets, 250 mg Inc.
(base).
ANDA 077784................. Risperidone Tablets, Ratiopharm Inc., c/o
0.25 mg, 0.5 mg, 1 Columbia Pharma
mg, 2 mg, 3 mg, and Consulting Services
4 mg. Inc., 490 Northwest
Datewood Dr., Suite
400, Issaquah, WA
98027.
ANDA 078241................. Sumatriptan Roxane Laboratories,
Succinate Tablets, Inc.
25 mg, 50 mg, and
100 mg (base).
ANDA 078318................. Sumatriptan TEVA Parenteral
Injection, 4 mg Medicines, Inc., 19
(base)/0.5 mL and 6 Hughes, Irvine, CA
mg (base)/0.5 mL. 92618.
ANDA 078416................. Prednisolone Sodium Vintage
Phosphate Oral Pharmaceuticals,
Solution, 5 mg 120 Vintage Dr.,
(base)/5 mL. Huntsville, AL
35811.
ANDA 078517................. Venlafaxine HCl PLIVA Hrvatska
Tablets, 25 mg d.o.o., c/o Barr
(base), 37.5 mg Laboratories, Inc.,
(base), 50 mg 400 Chestnut Ridge
(base), 75 mg Rd., Woodcliff
(base), and 100 mg Lake, NJ 07677
(base).
ANDA 080997................. Succinylcholine Organon USA Inc.
Chloride Injection
USP, 20 mg/mL.
ANDA 081125................. Dexamethasone Sodium TEVA Parenteral
Phosphate Injection Medicines, Inc., 19
USP, 4 mg/mL. Hughes, Irvine, CA
92618.
ANDA 081126................. Dexamethasone Sodium Do.
Phosphate Injection
USP.
ANDA 081298................. Chlorzoxazone Ranbaxy Inc., U.S.
Tablets, 250 mg. Agent for Ohm, 600
College Rd. East,
Princeton, NJ
08540.
ANDA 081299................. Chlorzoxazone Do.
Tablets, 500 mg.
ANDA 081310................. Fluphenazine HCl Teva Pharmaceuticals
Elixir USP, 2.5 mg/ USA.
5 mL.
ANDA 087005................. Trichlormethiazide Par Pharmaceutical,
Tablets, 4 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 087007................. Trichlormethiazide Do.
Tablets, 2 mg.
ANDA 087032................. Chlorpromazine HCl Morton Grove
Oral Concentrate Pharmaceuticals,
USP, 30 mg/mL. Inc., U.S. Agent
for Wockhardt EU
Operations (Swiss)
AG, 6451 West Main
St., Morton Grove,
IL 60053.
ANDA 087053................. Chlorpromazine HCl Do.
Oral Concentrate
USP, 100 mg/mL.
ANDA 087406................. Oxycodone and Barr Laboratories,
Acetaminophen Inc., 400 Chestnut
Tablets USP, 5 mg/ Ridge Rd.,
325 mg. Woodcliff Lake, NJ
07677.
ANDA 087585................. Potassium Chloride Luitpold
for Injection Pharmaceuticals,
Concentrate USP, 2 Inc., One Luitpold
mEq/mL. Dr., P.O. Box 9001,
Shirley, NY 11967.
ANDA 088143................. Trifluoperazine Oral Morton Grove
Solution USP, 10 mg/ Pharmaceuticals,
mL. Inc., U.S. Agent
for Wockhardt EU
Operations (Swiss)
AG.
ANDA 088194................. Thioridazine HCl Ivax
Tablets USP, 50 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA, 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 088227................. Thioridazine HCl Morton Grove
Oral Solution USP Pharmaceuticals,
(Concentrate), 100 Inc., U.S. Agent
mg/mL. for Wockhardt EU
Operations (Swiss)
AG.
ANDA 088258................. Thioridazine HCl Do.
Oral Solution USP
(Concentrate), 30
mg/mL.
ANDA 088270................. Thioridazine HCl Ivax
Tablets USP, 10 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA.
ANDA 088271................. Thioridazine HCl Do.
Tablets USP, 15 mg.
[[Page 16042]]
ANDA 088272................. Thioridazine HCl Do.
Tablets USP, 25 mg.
ANDA 088273................. Thioridazine HCl Do.
Tablets USP, 100 mg.
ANDA 088456................. Thioridazine HCl Teva Pharmaceuticals
Tablets USP, 100 mg. USA.
ANDA 088493................. Thioridazine HCl Do.
Tablets USP, 10 mg.
ANDA 088850................. Hydroflumethiazide Par Pharmaceutical,
Tablets USP, 50 mg. Inc.
ANDA 088907................. Reserpine and Do.
Hydroflumethiazide
Tablets, 0.125 mg/
50 mg.
ANDA 088933................. Sulfinpyrazone Do.
Tablets, 100 mg.
ANDA 088934................. Sulfinpyrazone Do.
Capsules USP, 200
mg.
ANDA 089135................. Methyclothiazide Do.
Tablets, 2.5 mg.
ANDA 089136................. Methyclothiazide Do.
Tablets, 5 mg.
ANDA 089173................. A-MethaPred Hospira, Inc.
(methylprednisolone
sodium succinate
for injection USP),
500 mg (base)/Vial.
ANDA 089174................. A-MethaPred Do.
(methylprednisolone
sodium succinate
for injection USP),
1 gram (base)/Vial.
ANDA 089207................. Methylprednisolone Par Pharmaceutical,
Tablets USP, 16 mg. Inc.
ANDA 089208................. Methylprednisolone Do.
Tablets USP, 24 mg.
ANDA 089209................. Methylprednisolone Do.
Tablets USP, 32 mg.
ANDA 089457................. Perphenazine Tablets Ivax
USP, 16 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA.
ANDA 089602................. Thioridazine HCl Teva Pharmaceuticals
Oral Solution USP, USA.
30 mg/mL.
ANDA 089603................. Thioridazine HCl Do.
Oral Solution USP,
100 mg/mL.
ANDA 089624................. Reversol Organon USA Inc.
(edrophonium
chloride injection
USP), 10 mg/mL).
ANDA 089657................. Methocarbamol and Par Pharmaceutical,
Aspirin Tablets, Inc.
400 mg/325 mg.
ANDA 089708................. Perphenazine Tablets Ivax
USP, 4 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA.
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\1\ This product included an oral pressurized metered-dose inhaler that
contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any albuterol or salmeterol metered-
dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December
7, 2006).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (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 April 18, 2012. 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 in
this document 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: February 16, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-6591 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P