Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen, 17163-17168 [2014-06801]
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Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
appropriate RLD with an
acetaminophen strength at or below 325
mg in the Orange Book. For a small
minority of higher acetaminophen
strength combinations, there is no
approved lower acetaminophen strength
product with the same active
ingredients that could serve as the RLD.
We believe that reformulations of these
products, however, could be approved
as ANDAs upon approval of an ANDA
suitability petition (see section
505(j)(2)(C) of the FD&C Act and
§ 314.93 (21 CFR 314.93)) permitting the
submission of an ANDA for a drug
product that is not identical to the RLD
in an active ingredient or unit dosage
strength, or could be approved as NDAs
following submission of applications
with appropriate clinical studies.
We are establishing a timeframe for
responding to this notice that takes into
account the estimated time needed for
sponsors to obtain necessary approvals
and begin to market new products with
lower acetaminophen strengths. We
believe that a period of 3 years from
publication of this notice in the Federal
Register will provide adequate time for
drug sponsors to prepare to withdraw
existing products with higher
acetaminophen strengths, and to
develop and obtain approval for lower
acetaminophen strength versions of
those products. We also anticipate that
this will provide sufficient time for drug
sponsors with approved lower
acetaminophen strength products to
expand their production to meet the
expected increase in demand for lower
acetaminophen strength products when
the higher strength products become
unavailable.
We strongly encourage sponsors of
combination prescription products with
acetaminophen strengths greater than
325 mg to submit requests for
withdrawal of those products’ approved
applications under § 314.150(d) within
the 3-year period described previously.
Sponsors who intend to seek approval
of one or more new products with
acetaminophen strengths of 325 mg or
less are encouraged to submit
appropriate applications for such
products in time to obtain approval
within the same period. To that end, we
welcome inquiries and requests for
consultation from sponsors relating to
specific existing or proposed products
in connection with this notice. Any
such requests from sponsors of currently
approved products affected by this
notice should be made as
correspondence under the affected
application(s) and should reference this
notice.
We are issuing this notice because we
believe that voluntary action on the part
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18:40 Mar 26, 2014
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of product sponsors to reduce the
acetaminophen strengths of prescription
acetaminophen combinations can
achieve the needed increase in patient
safety substantially sooner and with less
burden on public and private resources
than alternative regulatory measures.
However, FDA has authority under
section 505(e)(2) of the FD&C Act to
withdraw approval of an NDA or ANDA
if the Agency determines that the
‘‘* * * drug is not shown to be safe for
use under the conditions of use upon
the basis of which the drug was
approved * * *’’ based on
consideration of ‘‘* * * new evidence
* * * together with the evidence
available to [FDA] when the application
was approved * * *.’’ FDA regulations
describe the procedures for withdrawing
approval of an application. (See
§ 314.150 and 21 CFR 314.151, 314.200,
314.201, and 314.235). We intend to use
our authority under section 505(e) of the
FD&C Act to initiate withdrawal
proceedings for any prescription
acetaminophen combination products
with acetaminophen strengths greater
than 325 mg that remain on the market
3 years after the date of publication of
this notice.
Metabolism and Disposition 37:1779–
1784, 2009.
8. Lee W., Drug-Induced Hepatotoxicity, New
England Journal of Medicine, 349:474–
485, 2003.
9. Smilkstein, M. J. et al., ‘‘Efficacy of Oral
N-Acetylcysteine in the Treatment of
Acetaminophen Overdose, Analysis of
the National Multicenter Study (1976 to
1985),’’ New England Journal of
Medicine, 319:1557–62, 1988.
10. Nourjah, P. et al, ‘‘Estimates of
Acetaminophen (Paracetamol)-induced
Overdoses in the United States,’’
Pharacoepidemiological Drug Safety, 6:
406–409, 2006.
11. Lai, M. W. et al., ‘‘2005 Annual Report
of the American Association of Poison
Control Centers’ National Poisoning and
Exposure Database,’’ Clinical Toxicology,
44:803–932, 2006.
IV. References
FDA has verified the Web site address
in this reference section, but we are not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.
[Docket No. FDA–2011–N–0021]
1. FDA Center for Drug Evaluation and
Research, Acetaminophen Overdose and
Liver Injury—Background and Options
for Reducing Injury, Available on FDA’s
Web site at https://www.fda.gov/Advisory
Committees/CommitteesMeeting
Materials/Drugs/DrugSafetyandRisk
ManagementAdvisoryCommittee/
ucm126014.htm.
2. Schiodt, F. V. et al., ‘‘Acetaminophen
Toxicity in an Urban County Hospital,’’
New England Journal of Medicine,
337:1112–7, 1997.
3. Bower, W. A. et al., ‘‘Population-Based
Surveillance for Acute Liver Failure,’’
American Journal of Gastroenterology,
(102(11)):2459–63, 2007.
4. Larson, A. M. et al., ‘‘AcetaminophenInduced Acute Liver Failure: Results of
a United States Multicenter, Prospective
Study,’’ Hepatology, 42:1364–72, 2005.
5. Larson, A. M., ‘‘Acetaminophen
Hepatotoxicity,’’ Clinical Liver Disease,
11:525–48, vi, 2007.
6. Holme, J. A. et al., ‘‘Cytotoxic Effects of Nacetyl-p-Benzoquinone Imine, a
Common Arylating Intermediate of
Paracetamol and Nhydroxyparacetamol,’’ Biochemical
Pharmacology, Feb. 1:33(3), 1984.
7. James, L. P. et al., ‘‘Pharmacokinetics of
Acetaminophen—Protein Adducts in
Adults With Acetaminophen Overdose
and Acute Liver Failure,’’ Drug
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Dated: March 24, 2014.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2014–06802 Filed 3–26–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Actavis Totowa LLC, et al.; Withdrawal
of Approval of Abbreviated New Drug
Applications for Prescription Pain
Medications Containing More Than 325
Milligrams of Acetaminophen
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 108 abbreviated new drug
applications (ANDAs) for prescription
pain medications containing more than
325 milligrams (mg) of acetaminophen.
The holders of these ANDAs have
voluntarily requested that approval of
these applications be withdrawn and
have waived their opportunity for a
hearing.
DATES: Effective March 27, 2014.
FOR FURTHER INFORMATION CONTACT:
Rachel Turow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–5094.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 14, 2011 (76
FR 2691), FDA announced its plans to
reduce the maximum dosage unit
strength of acetaminophen in
prescription drug products. The notice
SUMMARY:
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Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
announced FDA’s conclusion that,
based on a reevaluation of the relative
risks and benefits of prescription
acetaminophen products, fixedcombination prescription drugs
containing more than 325 mg of
acetaminophen per dosage unit (tablet
or capsule) do not provide a sufficient
margin of safety to protect the public
against the serious risk of
acetaminophen-induced liver injury.
Accordingly, we asked product sponsors
to limit the maximum amount of
acetaminophen per dosage unit to 325
mg and, for those products containing
more than 325 mg of acetaminophen per
dosage unit, to submit requests that FDA
withdraw approval of their applications
under § 314.150(d) (21 CFR 314.150(d)).
FDA asked that all such requests be
made before January 14, 2014. Table 1
lists the applications for which FDA has
received such requests. The sponsors of
the applications listed in table 1 have
also waived their opportunity for a
hearing.
TABLE 1—APPLICATIONS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED
Application No.
Drug product(s)
Applicant or holder
ANDA 040199 ......
Acetaminophen and Oxycodone Hydrochloride Capsules,
500 mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 500
mg/7.5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Oxycodone Hydrochloride Capsules,
500 mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/2.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg Acetaminophen and Hydrocodone Bitartrate
Tablets, 650 mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/10 mg.
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate
Tablets, 712.8 mg/60 mg/32 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 500
mg/7.5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650
mg/10 mg.
Acetaminophen and Oxycodone Capsules, 500 mg/5 mg .....
Actavis Totowa LLC, 200 Elmora Ave., Elizabeth, NJ 07207.
ANDA 040748 ......
ANDA 040754 ......
ANDA 040757 ......
ANDA 040769 ......
ANDA 040789 ......
ANDA 040813 ......
ANDA 040729 ......
ANDA 040304 ......
ANDA 040307 ......
ANDA 040308 ......
ANDA 040309 ......
ANDA 040701 ......
ANDA 090265 ......
ANDA 090380 ......
ANDA 088898 ......
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 090177 ......
ANDA 040289 ......
ANDA 076202 ......
ANDA 089696 ......
VerDate Mar<15>2010
Acetaminophen and Pentazocine Hydrochloride Tablets, 650
mg/EQ 25 mg Base.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
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Amneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY
11788.
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Barr Laboratories Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10956.
Do.
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Boca Pharmacal LLC, 3550 Northwest 126th Ave., Coral
Springs, FL 33065.
Do.
Do.
Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect
Plains Rd., Cranbury, NJ 08512.
Do.
Do.
Do.
Do.
Central Pharmaceuticals Inc., 110–128 East 3rd St., Seymour, IN 47274.
Do.
Coastal Pharmaceuticals, 1240 Sugg Pkwy., Greenville, NC
27834.
Duramed Pharmaceuticals Inc., Sub Barr Laboratories Inc.,
2 Quaker Rd., P.O. Box 2900, Pomona, NY 10970–0519.
Gavis Pharmaceuticals, LLC, 400 Campus Dr., Somerset,
NJ 08873.
Ivax Pharmaceuticals Inc., 140 Legrand Ave., Northvale, NJ
07647.
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Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
17165
TABLE 1—APPLICATIONS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED—Continued
Application No.
Drug product(s)
ANDA 089907 ......
ALLAY (Acetaminophen and Hydrocodone Bitartrate) Capsules, 500 mg/5 mg.
TYLOX (Acetaminophen and Oxycodone Hydrochloride)
Capsules, 500 mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/10 mg.
Acetaminophen and Oxycodone Hydrochloride Capsules,
500 mg/5 mg.
LORCET–HD (Acetaminophen and Hydrocodone Bitartrate)
Capsules, 500 mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
BUCET (Acetaminophen and Butalbital) Capsules, 650 mg/
50 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
ANEXSIA (Acetaminophen and Hydrocodone Bitartrate)
Tablets, 500 mg/5 mg.
TENCON (Acetaminophen and Butalbital) Capsules, 650
mg/50 mg.
ANEXSIA 7.5/650 (Acetaminophen and Hydrocodone
Bitartrate) Tablets, 650 mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Oral Solution,
500 mg/15 mL;7.5 mg/15 mL.
ANEXSIA (Acetaminophen and Hydrocodone Bitartrate)
Tablets, 750 mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Oral Solution,
500 mg/15 mL;10 mg/15 mL.
Acetaminophen and Oxycodone Hydrochloride Tablets, 500
mg/7.5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650
mg/10 mg.
ESGIC–PLUS (Acetaminophen, Butalbital, and Caffeine)
Capsules, 500 mg/50 mg/40 mg.
Acetaminophen, Butalbital, and Caffeine Tablets, 750 mg/50
mg/40 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 500
mg/10 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 400
mg/2.5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 400
mg/5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 400
mg/10 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 400
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Oral Solution,
500 mg/15 mL; 7.5 mg/15 mL.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
ESGIC–PLUS (Acetaminophen, Butalbital, and Caffeine)
Tablets, 500 mg/50 mg/40 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/2.5 mg.
ANDA 088790 ......
ANDA 040084 ......
ANDA 040201 ......
ANDA 040257 ......
ANDA 087336 ......
ANDA 088956 ......
ANDA 088991 ......
ANDA 089006 ......
ANDA 089160 ......
ANDA 089405 ......
ANDA 089725 ......
ANDA 040418 ......
ANDA 040468 ......
ANDA 040508 ......
ANDA 040550 ......
ANDA 040085 ......
ANDA 040496 ......
ANDA 040676 ......
ANDA 040679 ......
ANDA 040687 ......
ANDA 040692 ......
ANDA 040698 ......
ANDA 040849 ......
ANDA 081051 ......
ANDA 081067 ......
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 081223 ......
ANDA 089008 ......
ANDA 089451 ......
ANDA 089689 ......
ANDA 089698 ......
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Fmt 4703
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Do.
Janssen Research & Development, LLC, 920 U.S. Hwy.
202, P.O. Box 300, Raritan, NJ 08869.
Do.
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Mallinckrodt Chemical Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
Do.
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Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
Do.
Do.
Do.
Do.
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Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
TABLE 1—APPLICATIONS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED—Continued
Application No.
Drug product(s)
ANDA 089699 ......
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
BUTAPAP (Acetaminophen and Butalbital) Tablets, 650 mg/
50 mg.
Acetaminophen and Codeine Phosphate Tablets, 650 mg/30
mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Codeine Phosphate Tablets, 650 mg/60
mg.
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate
Capsules, 356.4 mg/30 mg/16 mg.
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate
Tablets, 712.8 mg/60 mg/32 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Capsules, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Oral Solution,
500 mg/15 mL;5 mg/15 mL.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50
mg/40 mg.
Acetaminophen and Oxycodone Capsules, 500 mg/5 mg .....
ANDA 089988 ......
ANDA 089231 ......
ANDA 089271 ......
ANDA 089363 ......
ANDA 040109 ......
ANDA 040316 ......
ANDA 081068 ......
ANDA 081069 ......
ANDA 081070 ......
ANDA 089557 ......
ANDA 089697 ......
ANDA 040883 ......
ANDA 040219 ......
ANDA 040236 ......
ANDA 040240 ......
ANDA 040061 ......
ANDA 089775 ......
ANDA 040100 ......
ANDA 087722 ......
ANDA 087757 ......
ANDA 088831 ......
ANDA 040106 ......
ANDA 040143 ......
ANDA 040144 ......
ANDA 040155 ......
ANDA 040157 ......
ANDA 040356 ......
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 040358 ......
ANDA 040513 ......
ANDA 040520 ......
ANDA 089971 ......
ANDA 089831 ......
VerDate Mar<15>2010
Applicant or holder
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
ROXILOX (Acetaminophen and Oxycodone Hydrochloride)
Capsules, 500 mg/5 mg.
ROXICET 5/500 (Acetaminophen and Oxycodone Hydrochloride) Tablets, 500 mg/5 mg.
LORTAB (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/10 mg.
LORTAB (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg.
CO–GESIC (Acetaminophen and Hydrocodone Bitartrate)
Tablets, 500 mg/5 mg.
PHRENILIN FORTE (Acetaminophen and Butalbital) Capsules, 650 mg/50 mg.
Acetaminophen and Oxycodone Hydrochloride Capsules,
500 mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/2.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660
mg/10 mg.
Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50
mg/40 mg.
Acetaminophen and Hydrocodone Bitartrate Oral Solution,
500 mg/15 mL;7.5 mg/15 mL.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
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Mirror Pharmaceuticals LLC, 140 New Dutch Lane, Fairfield,
NJ 07004.
Mutual Pharmaceutical Co. Inc., 1100 Orthodox St., Philadelphia, PA 19124.
Do.
Do.
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Roxane Laboratories Inc., 1809 Wilson Rd., Columbus, OH
43228.
Do.
UCB Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA
30080.
Do.
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Valeant Pharmaceuticals North America LLC, 700 Route
202/206 North, Bridgewater, NJ 08807.
Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL
35811.
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Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
17167
TABLE 1—APPLICATIONS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED—Continued
Application No.
Drug product(s)
ANDA 040280 ......
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
ZYDONE (Acetaminophen and Hydrocodone Bitartrate) Tablets, 400 mg/5 mg.
ZYDONE (Acetaminophen and Hydrocodone Bitartrate) Tablets, 400 mg/7.5 mg.
ZYDONE (Acetaminophen and Hydrocodone Bitartrate) Tablets, 400 mg/10 mg.
Acetaminophen and Oxycodone Hydrochloride Capsules,
500 mg/5 mg.
PERCOCET (Acetaminophen and Oxycodone Hydrochloride) Tablets, 500 mg/7.5 mg.
PERCOCET (Acetaminophen and Oxycodone Hydrochloride) Tablets, 650 mg/10 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 500
mg/7.5 mg.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/10 mg.
Acetaminophen and Oxycodone Hydrochloride Capsules,
500 mg/5 mg.
Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50
mg/40 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/2.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/2.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650
mg/10 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500
mg/5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750
mg/7.5 mg.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660
mg/10 mg.
CODRIX (Acetaminophen and Codeine Phosphate) Tablets,
500 mg/30 mg.
CODRIX (Acetaminophen and Codeine Phosphate) Tablets,
500 mg/15 mg.
CODRIX (Acetaminophen and Codeine Phosphate) Tablets,
500 mg/60 mg.
Acetaminophen, Butalbital, and Caffeine Capsules, 500 mg/
50 mg/40 mg.
ANDA 040281 ......
ANDA 040288 ......
ANDA 040303 ......
ANDA 040341 ......
ANDA 040371 ......
ANDA 040094 ......
ANDA 040234 ......
ANDA 040267 ......
ANDA 081079 ......
ANDA 081080 ......
ANDA 081083 ......
ANDA 040122 ......
ANDA 040123 ......
ANDA 089883 ......
ANDA 040493 ......
ANDA 040494 ......
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 040495 ......
ANDA 040441 ......
ANDA 040447 ......
ANDA 040488 ......
ANDA 040261 ......
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Watson Laboratories, 311 Bonnie Circle, Corona, CA 92880.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Watson Laboratories Inc.—Florida, 2945 West Corporate
Lakes Blvd., Suite B, Weston, FL 33331.
Do.
Do.
Do.
Do.
Do.
West-Ward Pharmaceutical Corp., 435 Industrial Way West,
Eatontown, NJ 07724.
E:\FR\FM\27MRN1.SGM
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Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
TABLE 1—APPLICATIONS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED—Continued
Application No.
Drug product(s)
ANDA 040336 ......
Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50
mg/40 mg.
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate
Capsules, 356.4 mg/30 mg/16 mg.
ANDA 040688 ......
Therefore, under § 314.150(d), and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of the applications
for the drug products listed in table 1 of
this document, and all amendments and
supplements thereto, is withdrawn (see
DATES). Distribution of these products in
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
The safety issue discussed in this
document and the January 14, 2011,
Federal Register document is limited to
products containing more than 325 mg
of acetaminophen per dosage unit.
Thus, the withdrawal of approval of
products containing more than 325 mg
of acetaminophen per dosage unit listed
in table 1 does not change the approval
status of any products with 325 mg or
less of acetaminophen per dosage unit
that were approved under the same
application. In addition, the withdrawal
of approval of products containing more
than 325 mg of acetaminophen per
dosage unit does not change the
approval status of products with 325 mg
or less of acetaminophen per dosage
unit that refer to or rely on the
withdrawn products. For example, this
withdrawal action will not affect the
approval status of an ANDA for a
product that contains 325 mg or less per
dosage unit that references a product
listed in table 1, but for which FDA
approved a suitability petition for a
lower strength under section 505(j)(2)(C)
of the FD&C Act and § 314.93 (21 CFR
314.93)).
Dated: March 24, 2014.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2014–06801 Filed 3–26–14; 8:45 am]
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Ridgeland, MS 39157.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa-10
et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
SUMMARY:
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121
Marketridge
Dr.,
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions which may lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
if the petitioner shows that the
condition was caused by one of the
listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
February 1, 2014, through February 28,
2014. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
(a) ‘‘Sustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17163-17168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0021]
Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated
New Drug Applications for Prescription Pain Medications Containing More
Than 325 Milligrams of Acetaminophen
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 108 abbreviated new drug applications (ANDAs) for prescription pain
medications containing more than 325 milligrams (mg) of acetaminophen.
The holders of these ANDAs have voluntarily requested that approval of
these applications be withdrawn and have waived their opportunity for a
hearing.
DATES: Effective March 27, 2014.
FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 2011
(76 FR 2691), FDA announced its plans to reduce the maximum dosage unit
strength of acetaminophen in prescription drug products. The notice
[[Page 17164]]
announced FDA's conclusion that, based on a reevaluation of the
relative risks and benefits of prescription acetaminophen products,
fixed-combination prescription drugs containing more than 325 mg of
acetaminophen per dosage unit (tablet or capsule) do not provide a
sufficient margin of safety to protect the public against the serious
risk of acetaminophen-induced liver injury. Accordingly, we asked
product sponsors to limit the maximum amount of acetaminophen per
dosage unit to 325 mg and, for those products containing more than 325
mg of acetaminophen per dosage unit, to submit requests that FDA
withdraw approval of their applications under Sec. 314.150(d) (21 CFR
314.150(d)). FDA asked that all such requests be made before January
14, 2014. Table 1 lists the applications for which FDA has received
such requests. The sponsors of the applications listed in table 1 have
also waived their opportunity for a hearing.
Table 1--Applications for Which Withdrawal of Approval Has Been
Requested
------------------------------------------------------------------------
Application No. Drug product(s) Applicant or holder
------------------------------------------------------------------------
ANDA 040199............. Acetaminophen and Actavis Totowa LLC,
Oxycodone 200 Elmora Ave.,
Hydrochloride Elizabeth, NJ 07207.
Capsules, 500 mg/5 mg.
ANDA 040748............. Acetaminophen and Amneal
Hydrocodone Pharmaceuticals, 85
Bitartrate Tablets, Adams Ave.,
500 mg/7.5 mg. Hauppauge, NY 11788.
ANDA 040754............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
ANDA 040757............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
ANDA 040769............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040789............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 500 mg/7.5
mg.
Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 650 mg/10 mg.
ANDA 040813............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/10 mg.
ANDA 040729............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
ANDA 040304............. Acetaminophen and Barr Laboratories
Oxycodone Inc., 2 Quaker Rd.,
Hydrochloride P.O. Box 2900,
Capsules, 500 mg/5 mg. Pomona, NY 10956.
ANDA 040307............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/2.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg
Acetaminophen and
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
ANDA 040308............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040309............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/10 mg.
ANDA 040701............. Acetaminophen, Boca Pharmacal LLC,
Caffeine, and 3550 Northwest 126th
Dihydrocodeine Ave., Coral Springs,
Bitartrate Tablets, FL 33065.
712.8 mg/60 mg/32 mg.
ANDA 090265............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
Acetaminophen and Caraco Pharmaceutical
Hydrocodone Laboratories, Ltd.,
Bitartrate Tablets, 270 Prospect Plains
500 mg/10 mg. Rd., Cranbury, NJ
08512.
ANDA 090380............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
660 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 088898............. Acetaminophen and Central
Hydrocodone Pharmaceuticals Inc.,
Bitartrate Capsules, 110-128 East 3rd St.,
500 mg/5 mg. Seymour, IN 47274.
ANDA 090177............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 500 mg/7.5
mg.
Acetaminophen and Coastal
Oxycodone Pharmaceuticals, 1240
Hydrochloride Sugg Pkwy.,
Tablets, 650 mg/10 mg. Greenville, NC 27834.
ANDA 040289............. Acetaminophen and Duramed
Oxycodone Capsules, Pharmaceuticals Inc.,
500 mg/5 mg. Sub Barr Laboratories
Inc., 2 Quaker Rd.,
P.O. Box 2900,
Pomona, NY 10970-
0519.
ANDA 076202............. Acetaminophen and Gavis Pharmaceuticals,
Pentazocine LLC, 400 Campus Dr.,
Hydrochloride Somerset, NJ 08873.
Tablets, 650 mg/EQ 25
mg Base.
ANDA 089696............. Acetaminophen and Ivax Pharmaceuticals
Hydrocodone Inc., 140 Legrand
Bitartrate Tablets, Ave., Northvale, NJ
500 mg/5 mg. 07647.
[[Page 17165]]
ANDA 089907............. ALLAY (Acetaminophen Do.
and Hydrocodone
Bitartrate) Capsules,
500 mg/5 mg.
ANDA 088790............. TYLOX (Acetaminophen Janssen Research &
and Oxycodone Development, LLC, 920
Hydrochloride) U.S. Hwy. 202, P.O.
Capsules, 500 mg/5 mg. Box 300, Raritan, NJ
08869.
ANDA 040084............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
Acetaminophen and Mallinckrodt Chemical
Hydrocodone Inc., 675 McDonnell
Bitartrate Tablets, Blvd., Hazelwood, MO
660 mg/10 mg. 63042.
ANDA 040201............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/10 mg.
ANDA 040257............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Capsules, 500 mg/5 mg.
ANDA 087336............. LORCET-HD Do.
(Acetaminophen and
Hydrocodone
Bitartrate) Capsules,
500 mg/5 mg.
ANDA 088956............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 088991............. BUCET (Acetaminophen Do.
and Butalbital)
Capsules, 650 mg/50
mg.
ANDA 089006............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 089160............. ANEXSIA (Acetaminophen Do.
and Hydrocodone
Bitartrate) Tablets,
500 mg/5 mg.
ANDA 089405............. TENCON (Acetaminophen Do.
and Butalbital)
Capsules, 650 mg/50
mg.
ANDA 089725............. ANEXSIA 7.5/650 Do.
(Acetaminophen and
Hydrocodone
Bitartrate) Tablets,
650 mg/7.5 mg.
ANDA 040418............. Acetaminophen and Do.
Hydrocodone
Bitartrate Oral
Solution, 500 mg/15
mL;7.5 mg/15 mL.
ANDA 040468............. ANEXSIA (Acetaminophen Do.
and Hydrocodone
Bitartrate) Tablets,
750 mg/10 mg.
ANDA 040508............. Acetaminophen and Do.
Hydrocodone
Bitartrate Oral
Solution, 500 mg/15
mL;10 mg/15 mL.
ANDA 040550............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 500 mg/7.5
mg.
Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 650 mg/10 mg.
ANDA 040085............. ESGIC-PLUS Mikart, Inc., 1750
(Acetaminophen, Chattahoochee Ave.,
Butalbital, and Atlanta, GA 30318.
Caffeine) Capsules,
500 mg/50 mg/40 mg.
ANDA 040496............. Acetaminophen, Do.
Butalbital, and
Caffeine Tablets, 750
mg/50 mg/40 mg.
ANDA 040676............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 500 mg/10 mg.
ANDA 040679............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 400 mg/2.5
mg.
ANDA 040687............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 400 mg/5 mg.
ANDA 040692............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 400 mg/10 mg.
ANDA 040698............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 400 mg/7.5
mg.
ANDA 040849............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/5 mg.
ANDA 081051............. Acetaminophen and Do.
Hydrocodone
Bitartrate Oral
Solution, 500 mg/15
mL; 7.5 mg/15 mL.
ANDA 081067............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 081223............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
ANDA 089008............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 089451............. ESGIC-PLUS Do.
(Acetaminophen,
Butalbital, and
Caffeine) Tablets,
500 mg/50 mg/40 mg.
ANDA 089689............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
ANDA 089698............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/2.5 mg.
[[Page 17166]]
ANDA 089699............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
ANDA 089988............. BUTAPAP (Acetaminophen Do.
and Butalbital)
Tablets, 650 mg/50 mg.
ANDA 089231............. Acetaminophen and Do.
Codeine Phosphate
Tablets, 650 mg/30 mg.
ANDA 089271............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
ANDA 089363............. Acetaminophen and Do.
Codeine Phosphate
Tablets, 650 mg/60 mg.
ANDA 040109............. Acetaminophen, Do.
Caffeine, and
Dihydrocodeine
Bitartrate Capsules,
356.4 mg/30 mg/16 mg.
ANDA 040316............. Acetaminophen, Do.
Caffeine, and
Dihydrocodeine
Bitartrate Tablets,
712.8 mg/60 mg/32 mg.
ANDA 081068............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 081069............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 081070............. Acetaminophen and Do.
Hydrocodone
Bitartrate Capsules,
500 mg/5 mg.
ANDA 089557............. Acetaminophen and Do.
Hydrocodone
Bitartrate Oral
Solution, 500 mg/15
mL;5 mg/15 mL.
ANDA 089697............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
ANDA 040883............. Acetaminophen, Mirror Pharmaceuticals
Butalbital, and LLC, 140 New Dutch
Caffeine Tablets, 500 Lane, Fairfield, NJ
mg/50 mg/40 mg. 07004.
ANDA 040219............. Acetaminophen and Mutual Pharmaceutical
Oxycodone Capsules, Co. Inc., 1100
500 mg/5 mg. Orthodox St.,
Philadelphia, PA
19124.
ANDA 040236............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040240............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
ANDA 040061............. ROXILOX (Acetaminophen Roxane Laboratories
and Oxycodone Inc., 1809 Wilson
Hydrochloride) Rd., Columbus, OH
Capsules, 500 mg/5 mg. 43228.
ANDA 089775............. ROXICET 5/500 Do.
(Acetaminophen and
Oxycodone
Hydrochloride)
Tablets, 500 mg/5 mg.
ANDA 040100............. LORTAB (Acetaminophen UCB Inc., 1950 Lake
and Hydrocodone Park Dr., Bldg. 2100,
Bitartrate) Tablets, Smyrna, GA 30080.
500 mg/10 mg.
ANDA 087722............. LORTAB (Acetaminophen Do.
and Hydrocodone
Bitartrate) Tablets,
500 mg/5 mg.
ANDA 087757............. CO-GESIC Do.
(Acetaminophen and
Hydrocodone
Bitartrate) Tablets,
500 mg/5 mg.
ANDA 088831............. PHRENILIN FORTE Valeant
(Acetaminophen and Pharmaceuticals North
Butalbital) Capsules, America LLC, 700
650 mg/50 mg. Route 202/206 North,
Bridgewater, NJ
08807.
ANDA 040106............. Acetaminophen and Vintage
Oxycodone Pharmaceuticals, 150
Hydrochloride Vintage Dr.,
Capsules, 500 mg/5 mg. Huntsville, AL 35811.
ANDA 040143............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
ANDA 040144............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/2.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
ANDA 040155............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
ANDA 040157............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040356............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/10 mg.
ANDA 040358............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
660 mg/10 mg.
ANDA 040513............. Acetaminophen, Do.
Butalbital, and
Caffeine Tablets, 500
mg/50 mg/40 mg.
ANDA 040520............. Acetaminophen and Do.
Hydrocodone
Bitartrate Oral
Solution, 500 mg/15
mL;7.5 mg/15 mL.
ANDA 089971............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
ANDA 089831............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
[[Page 17167]]
ANDA 040280............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
ANDA 040281............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040288............. ZYDONE (Acetaminophen Do.
and Hydrocodone
Bitartrate) Tablets,
400 mg/5 mg.
ZYDONE (Acetaminophen Do.
and Hydrocodone
Bitartrate) Tablets,
400 mg/7.5 mg.
ZYDONE (Acetaminophen Do.
and Hydrocodone
Bitartrate) Tablets,
400 mg/10 mg.
ANDA 040303............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Capsules, 500 mg/5 mg.
ANDA 040341............. PERCOCET Do.
(Acetaminophen and
Oxycodone
Hydrochloride)
Tablets, 500 mg/7.5
mg.
PERCOCET Do.
(Acetaminophen and
Oxycodone
Hydrochloride)
Tablets, 650 mg/10 mg.
ANDA 040371............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Tablets, 500 mg/7.5
mg.
Acetaminophen and Watson Laboratories,
Oxycodone 311 Bonnie Circle,
Hydrochloride Corona, CA 92880.
Tablets, 650 mg/10 mg.
ANDA 040094............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
660 mg/10 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/10 mg.
ANDA 040234............. Acetaminophen and Do.
Oxycodone
Hydrochloride
Capsules, 500 mg/5 mg.
ANDA 040267............. Acetaminophen, Do.
Butalbital, and
Caffeine Tablets, 500
mg/50 mg/40 mg.
ANDA 081079............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/2.5 mg.
ANDA 081080............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
ANDA 081083............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040122............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040123............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/2.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/7.5 mg.
Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
650 mg/10 mg.
ANDA 089883............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
500 mg/5 mg.
ANDA 040493............. Acetaminophen and Watson Laboratories
Hydrocodone Inc.--Florida, 2945
Bitartrate Tablets, West Corporate Lakes
500 mg/5 mg. Blvd., Suite B,
Weston, FL 33331.
ANDA 040494............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
750 mg/7.5 mg.
ANDA 040495............. Acetaminophen and Do.
Hydrocodone
Bitartrate Tablets,
660 mg/10 mg.
ANDA 040441............. CODRIX (Acetaminophen Do.
and Codeine
Phosphate) Tablets,
500 mg/30 mg.
ANDA 040447............. CODRIX (Acetaminophen Do.
and Codeine
Phosphate) Tablets,
500 mg/15 mg.
ANDA 040488............. CODRIX (Acetaminophen Do.
and Codeine
Phosphate) Tablets,
500 mg/60 mg.
ANDA 040261............. Acetaminophen, West-Ward
Butalbital, and Pharmaceutical Corp.,
Caffeine Capsules, 435 Industrial Way
500 mg/50 mg/40 mg. West, Eatontown, NJ
07724.
[[Page 17168]]
ANDA 040336............. Acetaminophen, Do.
Butalbital, and
Caffeine Tablets, 500
mg/50 mg/40 mg.
ANDA 040688............. Acetaminophen, WraSer Pharmaceuticals
Caffeine, and LLC, 121 Marketridge
Dihydrocodeine Dr., Ridgeland, MS
Bitartrate Capsules, 39157.
356.4 mg/30 mg/16 mg.
------------------------------------------------------------------------
Therefore, under Sec. 314.150(d), and under authority delegated to
the Director, Center for Drug Evaluation and Research, by the
Commissioner of Food and Drugs, approval of the applications for the
drug products listed in table 1 of this document, and all amendments
and supplements thereto, is withdrawn (see DATES). Distribution of
these products in interstate commerce without an approved application
is illegal and subject to regulatory action (see sections 505(a) and
301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
The safety issue discussed in this document and the January 14,
2011, Federal Register document is limited to products containing more
than 325 mg of acetaminophen per dosage unit. Thus, the withdrawal of
approval of products containing more than 325 mg of acetaminophen per
dosage unit listed in table 1 does not change the approval status of
any products with 325 mg or less of acetaminophen per dosage unit that
were approved under the same application. In addition, the withdrawal
of approval of products containing more than 325 mg of acetaminophen
per dosage unit does not change the approval status of products with
325 mg or less of acetaminophen per dosage unit that refer to or rely
on the withdrawn products. For example, this withdrawal action will not
affect the approval status of an ANDA for a product that contains 325
mg or less per dosage unit that references a product listed in table 1,
but for which FDA approved a suitability petition for a lower strength
under section 505(j)(2)(C) of the FD&C Act and Sec. 314.93 (21 CFR
314.93)).
Dated: March 24, 2014.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2014-06801 Filed 3-26-14; 8:45 am]
BILLING CODE 4160-01-P
