[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72186-72188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1795]
Mallinckrodt Inc. et al.; Withdrawal of Approval of 23 New Drug
Applications and 68 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 23 new drug applications (NDAs) and 68 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be withdrawn.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: January 5, 2015.
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 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 pursuant to 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 002852............. Plexofer Mallinckrodt Inc., 675
(multivitamins) Syrup. McDonnell Blvd.,
Hazelwood, MO 63042.
NDA 008719............. Levo-Dromoran Valeant
(levorphanol tartrate) Pharmaceuticals North
Injection, 2 America LLC, 400
milligrams (mg)/ Somerset Corporate
milliliter (mL). Blvd., Bridgewater,
NJ 08807.
NDA 008720............. Levo-Dromoran Do.
(levorphanol tartrate)
Tablets, 2 mg.
NDA 011777............. Sodium Phosphate P 32 Mallinckrodt Inc.
Solution.
NDA 012366............. Soma Compound with Meda Pharmaceuticals
Codeine (carisoprodol, Inc., 265 Davidson
aspirin, and codeine Ave., Suite 300,
phosphate). Somerset, NJ 08873-
4120.
NDA 012708............. Diutensen-R Do.
(methyclothiazide and
reserpine) Tablets,
2.5 mg/0.1 mg.
NDA 016245............. Vercyte (pipobroman) AbbVie, Inc., 1 North
Tablets. Waukegan Rd., Dept.
PA 77/Bldg. AP30,
North Chicago, IL
60064.
NDA 017463............. Motrin (ibuprofen) McNeil Consumer
Tablets, 300 mg, 400 Healthcare Division
mg, 600 mg, and 800 mg. of McNeil-PPC, Inc.,
7050 Camp Hill Rd.,
Fort Washington, PA
19034-2299.
NDA 018310............. Lymphazurin (isosulfan Covidien, 60
blue), 1%. Middletown Ave.,
North Haven, CT
06473.
NDA 018340............. Aerobid (flunisolide) Roche Palo Alto LLC, c/
Inhalation Aerosol \1\. o Genentech Inc., 1
DNA Way, South San
Francisco, CA 94080-
4990.
NDA 018731............. Buspar (buspirone Bristol-Myers Squibb
hydrochloride (HCl)) Co., P.O. Box 4000,
Tablets, 5 mg, 10 mg, Princeton, NJ 08543-
15 mg, and 30 mg. 4000.
NDA 019453............. Drixoral Merck Consumer Care,
(dexbrompheniramine 556 Morris Ave.,
maleate, Summit, NJ 07901.
pseudoephedrine
sulfate, and
acetaminophen)
Extended-Release
Tablets, 3 mg, 60 mg,
and 500 mg.
[[Page 72187]]
NDA 019842............. Motrin (ibuprofen) McNeil Consumer
Suspension, 100 mg/5 Healthcare Division
mL. of McNeil-PPC, Inc.
NDA 020150............. Nicotrol TD (nicotine Do.
transdermal system), 5
mg/16 hour (hr), 10 mg/
16 hr, and 15 mg/16 hr.
NDA 020707............. Skelid (tiludronate Sanofi-Aventis U.S.
disodium) Tablets. LLC, 55 Corporate
Dr., Mailstop 55C-
205A, Bridgewater, NJ
08807.
NDA 021043............. RID Mousse (pyrethrins Bayer Healthcare LLC,
0.33% and piperonyl 100 Bayer Blvd.,
butoxide 4.0%) Topical Whippany, NJ 07981-
Aerosol. 0915.
NDA 021082............. Tavist Allergy Sinus Novartis Consumer
Headache (clemastine Health, Inc., 200
fumarate, Kimball Dr.,
pseudoephedrine HCl, Parsippany, NJ 07054.
and acetaminophen)
Tablets, 0.335 mg, 30
mg, and 500 mg.
NDA 021190............. Buspar (buspirone HCl) Bristol-Myers Squibb
Capsules, 5 mg, 7.5 Co.
mg, 10 mg, and 15 mg.
NDA 021335............. Gleevac (imatinib Novartis
mesylate) Capsules, 50 Pharmaceuticals
mg and 100 mg. Corp., One Health
Plaza, East Hanover,
NJ 07936.
NDA 021745............. Ryzolt (tramadol HCl) Purdue Pharma Products
Extended-Release L.P., One Stamford
Tablets, 100 mg, 200 Forum, Stamford, CT
mg, and 300 mg. 06901-3431.
NDA 022217............. Valturna (aliskiren and Novartis
valsartan) Tablets. Pharmaceuticals Corp.
NDA 022470............. Nexcede (ketoprofen) Novartis Consumer
Oral Soluble Films, Health, Inc.
12.5 mg.
ANDA 040034............ Theophylline Extended- Inwood Laboratories,
Release Tablets, 450 Inc., Subsidiary of
mg. Forest Laboratories,
Inc., Harborside
Financial Center,
Plaza Five, Suite
1900, Jersey City, NJ
07311.
ANDA 040052............ Theophylline Extended- Do.
Release Capsules, 100
mg, 125 mg, 200 mg,
and 300 mg.
ANDA 040365............ Dextroamphetamine Nesher Pharmaceutical
Sulfate Tablets, 5 mg. (USA) LLC, 13910
Saint Charles Rock
Rd., Bridgeton, MO
63044.
ANDA 040367............ Dextroamphetamine Do.
Sulfate Tablets, 10 mg.
ANDA 060578............ Mycostatin Topical Delcor Asset Corp., c/
Powder (nystatin o Prestium Pharma
topical powder USP) Inc., 411 South State
100,000 units/gram (g). St., Suite E-100,
Newtown, PA 18940.
ANDA 062162............ Erythromycin Estolate Barr Laboratories,
Capsules USP, 125 mg Inc., Subsidiary of
and 250 mg. Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 062256............ Erythromycin Do.
Ethylsuccinate Tablets
USP, 400 mg.
ANDA 062773............ Cephalexin Capsules USP Do.
250 mg.
ANDA 062850............ Cephradine Capsules USP Do.
250 mg.
ANDA 062851............ Cephradine Capsules USP Do.
500 mg.
ANDA 062858............ Cephradine for Oral Do.
Suspension USP 125 mg/
5 mL.
ANDA 062859............ Cephradine for Oral Do.
Suspension USP, 250 mg/
5 mL.
ANDA 063016............ Cefazolin for Injection Teva Pharmaceuticals
USP 250 mg/vial, 500 USA, 425 Privet Rd.,
mg/vial, and 1 g/vial. Horsham, PA 19044.
ANDA 063028............ Erythromycin Delayed- Barr Laboratories,
Release Tablets USP, Inc., Subsidiary of
333 mg. Teva Pharmaceuticals
USA.
ANDA 063086............ Erythromycin Delayed- Do.
Release Tablets, 333
mg.
ANDA 063098............ Erythromycin Delayed- Do.
Release Capsules USP,
250 mg.
ANDA 063179............ Erythromycin Stearate ANI Pharmaceuticals,
Tablets USP 500 mg. Inc., 210 Main St.
West, Baudette, MN
56623.
ANDA 064191............ Cefuroxime for Teva Pharmaceuticals
Injection USP 7.5 g/ USA.
vial.
ANDA 064192............ Cefuroxime for Do.
Injection USP 750 mg/
vial and 1.5 g/vial.
ANDA 065032............ Doxycycline Capsules Sandoz Inc., 4700
USP 50 mg and 100 mg. Sandoz Dr., Wilson,
NC 27893.
ANDA 065227............ Ceftriaxone for Teva Pharmaceuticals
Injection USP, 250 mg/ USA.
vial, 500 mg/vial, 1 g/
vial, and 2 g/vial.
ANDA 065262............ Ceftriaxone for Do.
Injection USP, 1 g/
vial and 2 g/vial.
ANDA 065274............ Ceftriaxone for Do.
Injection USP, 10 g/
vial.
ANDA 070034............ Sulfamethoxazole and Teva Pharmaceuticals
Trimethoprim Tablets USA.
USP 400 mg/80 mg.
ANDA 070216............ Sulfamethoxazole and Barr Laboratories
Trimethoprim Tablets Inc., Subsidiary of
USP 800 mg/160 mg. Teva Pharmaceuticals.
ANDA 072410............ Indomethacin Extended- Inwood Laboratories,
Release Capsules, 75 Inc., Subsidiary of
mg. Forest Laboratories,
Inc.
ANDA 072499............ Propranolol HCl Do.
Extended-Release
Capsules, 60 mg.
ANDA 072500............ Propranolol HCl Do.
Extended-Release
Capsules, 80 mg.
ANDA 072501............ Propranolol HCl Do.
Extended-Release
Capsules, 120 mg.
ANDA 072502............ Propranolol HCl Do.
Extended-Release
Capsules, 160 mg.
ANDA 072619............ Albuterol Sulfate Teva Pharmaceuticals
Tablets USP 2 mg. USA.
ANDA 072620............ Albuterol Sulfate Do.
Tablets USP 4 mg.
ANDA 073095............ Clemastine Fumerate Do.
Syrup, 0.5 mg/5 mL.
ANDA 073531............ Potassium Chloride Do.
Extended-Release
Capsules USP, 8
milliequivalents (mEq).
ANDA 073532............ Potassium Chloride Do.
Extended-Release
Capsules USP, 10 mEq.
ANDA 073667............ Nortriptyline HCl Do.
Capsules, 10 mg, 25
mg, 50 mg, and 75 mg.
ANDA 074043............ Piroxicam Capsules USP, Mylan Pharmaceuticals,
10 mg and 20 mg. Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown, WV
26505.
[[Page 72188]]
ANDA 074126............ Atenolol Tablets USP, Do.
25 mg, 50 mg, and 100
mg.
ANDA 074589............ Minoxidil Topical Teva Pharmaceuticals
Solution, 2%. USA.
ANDA 074828............ Acyclovir Capsules, 200 Do.
mg.
ANDA 074849............ Clomipramine HCl Do.
Capsules, 25 mg, 50
mg, and 75 mg.
ANDA 074879............ Ketoprofen Extended- Alkermes Gainesville
Release Capsules, 200 LLC, 1300 Gould Dr.,
mg. Gainesville, GA
30504.
ANDA 074976............ Acyclovir Tablets USP, Mylan Pharmaceuticals,
400 mg and 800 mg. Inc.
ANDA 074977............ Acyclovir Capsules USP, Do.
200 mg.
ANDA 075161............ Ticlopidine HCl Tablets Do.
USP, 250 mg.
ANDA 075472............ Enalapril Maleate Do.
Tablets USP, 2.5 mg, 5
mg, 10 mg, and 20 mg.
ANDA 075934............ Nizatidine Capsules Do.
USP, 150 mg and 300 mg.
ANDA 076036............ Quinapril Tablets USP, Do.
5 mg, 10 mg, 20 mg,
and 40 mg.
ANDA 076969............ Metoprolol Succinate Sandoz, Inc.
Extended-Release
Tablets USP, 25 mg, 50
mg, 100 mg, and 200 mg.
ANDA 077136............ Terbinafine HCl Mylan Pharmaceuticals,
Tablets, 250 mg. Inc.
ANDA 077163............ Sumatriptan Succinate Do.
Tablets, 25 mg, 50 mg,
and 100 mg.
ANDA 077254............ Divalproex Sodium Do.
Delayed-Release
Tablets USP, 125 mg,
250 mg, and 500 mg.
ANDA 077486............ Glimepiride Tablets Do.
USP, 1 mg, 2 mg, and 4
mg.
ANDA 077705............ Fosinopril Sodium and Do.
Hydrochlorothiazide
Tablets, 10 mg/12.5 mg
and 20 mg/12.5 mg.
ANDA 077934............ Meloxicam Tablets USP, Do.
7.5 mg and 15 mg.
ANDA 077976............ Cromolyn Sodium Nasal HH & P LLC, c/o Kuker
Solution USP, 5.2 mg/1 Regulatory
spray. Consulting, LLC, 18
Dunbar Way,
Mahtomedi, MN 55115.
ANDA 078638............ Alendronate Sodium Mylan Pharmaceuticals,
Tablets USP, 35 mg and Inc.
70 mg.
ANDA 078731............ Levetiracetam Tablets, Do.
250 mg, 500 mg, 750
mg, and 1,000 mg.
ANDA 079184............ Ursodiol Tablets USP, Teva Pharmaceuticals
250 mg and 500 mg. USA.
ANDA 081295............ Estradiol Tablets USP, Bristol-Myers Squibb
0.5 mg. Co.
ANDA 084499............ Estradiol Tablets USP, Do.
1 mg.
ANDA 084500............ Estradiol Tablets USP, Do.
2 mg.
ANDA 085794............ Acetaminophen and Mutual Pharmaceutical
Codeine Phosphate Co., Inc., 1100
Tablets USP, 300 mg/30 Orthodox St.,
mg. Philadelphia, PA
19124.
ANDA 085795............ Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/15
mg.
ANDA 087176............ Chlorthalidone Tablets Ivax Pharmaceuticals,
USP, 50 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 087653............ Acetaminophen and Mutual Pharmaceutical
Codeine Phosphate Co., Inc.
Tablets USP, 300 mg/60
mg.
ANDA 088833............ Triprolidine HCl, Wockhardt Bio AG, c/o
pseudoephedrine HCl, Morton Grove
and Codeine Phosphate Pharmaceuticals,
Cough Syrup, 1.25 mg/5 Inc., 6451 Main St.,
mL, 30 mg/5 mL, and 10 Morton Grove, IL
mg/5 mL. 60053.
ANDA 088896............ Promethazine VC with Do.
Codeine (promethazine
HCl, phenylephrine
HCl, and codeine
phosphate) Cough
Syrup, 6.25 mg/5 mL, 5
mg/5 mL, and 10 mg/5
mL.
NDA 202343............. Juvisync (sitagliptin Merck Sharp & Dohme
and simvastatin) Corp., 351 North
Tablets, 100 mg/10 mg, Sumneytown Pike, P.O.
100 mg/20 mg, and 100 Box 1000, UG2CD-015,
mg/40 mg. North Wales, PA
19454.
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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 flunisolide metered-dose
inhalers (see 75 FR 19213, April 14, 2010).
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 January 5, 2015. 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: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28541 Filed 12-4-14; 8:45 am]
BILLING CODE 4164-01-P