[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17163-17168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06801]
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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.
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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these applications be withdrawn and have waived their opportunity for a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.
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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