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79 FR 59 pgs. 17163-17168 - Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen

Type: NOTICEVolume: 79Number: 59Pages: 17163 - 17168
Docket number: [Docket No. FDA-2011-N-0021]
FR document: [FR Doc. 2014-06801 Filed 3-26-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 17163, 17164, 17165

[top] page 17163

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 The holders of these ANDAs have voluntarily requested that approval of these applications be withdrawn and have waived their opportunity for a hearing.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:


[top] 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 § 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.

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Application No. Drug product(s) Applicant or holder
ANDA 040199 Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg Actavis Totowa LLC, 200 Elmora Ave., Elizabeth, NJ 07207.
ANDA 040748 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Amneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY 11788.
ANDA 040754 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
ANDA 040757 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
ANDA 040769 Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040789 Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mg Do.
ANDA 040813 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg Do.
ANDA 040729 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
ANDA 040304 Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg Barr Laboratories Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10956.
ANDA 040307 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
ANDA 040308 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040309 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg Do.
ANDA 040701 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, 712.8 mg/60 mg/32 mg Boca Pharmacal LLC, 3550 Northwest 126th Ave., Coral Springs, FL 33065.
ANDA 090265 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Rd., Cranbury, NJ 08512.
ANDA 090380 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 088898 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Central Pharmaceuticals Inc., 110-128 East 3rd St., Seymour, IN 47274.
ANDA 090177 Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mg Coastal Pharmaceuticals, 1240 Sugg Pkwy., Greenville, NC 27834.
ANDA 040289 Acetaminophen and Oxycodone Capsules, 500 mg/5 mg Duramed Pharmaceuticals Inc., Sub Barr Laboratories Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10970-0519.
ANDA 076202 Acetaminophen and Pentazocine Hydrochloride Tablets, 650 mg/EQ 25 mg Base Gavis Pharmaceuticals, LLC, 400 Campus Dr., Somerset, NJ 08873.
ANDA 089696 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Ivax Pharmaceuticals Inc., 140 Legrand Ave., Northvale, NJ 07647.
ANDA 089907 ALLAY (Acetaminophen and Hydrocodone Bitartrate) Capsules, 500 mg/5 mg Do.
ANDA 088790 TYLOX (Acetaminophen and Oxycodone Hydrochloride) Capsules, 500 mg/5 mg Janssen Research & Development, LLC, 920 U.S. Hwy. 202, P.O. Box 300, Raritan, NJ 08869.
ANDA 040084 Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg Mallinckrodt Chemical Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
ANDA 040201 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg Do.
ANDA 040257 Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg Do.
ANDA 087336 LORCET-HD (Acetaminophen and Hydrocodone Bitartrate) Capsules, 500 mg/5 mg Do.
ANDA 088956 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 088991 BUCET (Acetaminophen and Butalbital) Capsules, 650 mg/50 mg Do.
ANDA 089006 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 089160 ANEXSIA (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg Do.
ANDA 089405 TENCON (Acetaminophen and Butalbital) Capsules, 650 mg/50 mg Do.
ANDA 089725 ANEXSIA 7.5/650 (Acetaminophen and Hydrocodone Bitartrate) Tablets, 650 mg/7.5 mg Do.
ANDA 040418 Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;7.5 mg/15 mL Do.
ANDA 040468 ANEXSIA (Acetaminophen and Hydrocodone Bitartrate) Tablets, 750 mg/10 mg Do.
ANDA 040508 Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;10 mg/15 mL Do.
ANDA 040550 Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mg Do.
ANDA 040085 ESGIC-PLUS (Acetaminophen, Butalbital, and Caffeine) Capsules, 500 mg/50 mg/40 mg Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
ANDA 040496 Acetaminophen, Butalbital, and Caffeine Tablets, 750 mg/50 mg/40 mg Do.
ANDA 040676 Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/10 mg Do.
ANDA 040679 Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/2.5 mg Do.
ANDA 040687 Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/5 mg Do.
ANDA 040692 Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/10 mg Do.
ANDA 040698 Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/7.5 mg Do.
ANDA 040849 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/5 mg Do.
ANDA 081051 Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL; 7.5 mg/15 mL Do.
ANDA 081067 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 081223 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
ANDA 089008 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 089451 ESGIC-PLUS (Acetaminophen, Butalbital, and Caffeine) Tablets, 500 mg/50 mg/40 mg Do.
ANDA 089689 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
ANDA 089698 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg Do.
ANDA 089699 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
ANDA 089988 BUTAPAP (Acetaminophen and Butalbital) Tablets, 650 mg/50 mg Do.
ANDA 089231 Acetaminophen and Codeine Phosphate Tablets, 650 mg/30 mg Do.
ANDA 089271 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
ANDA 089363 Acetaminophen and Codeine Phosphate Tablets, 650 mg/60 mg Do.
ANDA 040109 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Capsules, 356.4 mg/30 mg/16 mg Do.
ANDA 040316 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, 712.8 mg/60 mg/32 mg Do.
ANDA 081068 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 081069 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 081070 Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg Do.
ANDA 089557 Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;5 mg/15 mL Do.
ANDA 089697 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
ANDA 040883 Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg Mirror Pharmaceuticals LLC, 140 New Dutch Lane, Fairfield, NJ 07004.
ANDA 040219 Acetaminophen and Oxycodone Capsules, 500 mg/5 mg Mutual Pharmaceutical Co. Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 040236 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040240 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
ANDA 040061 ROXILOX (Acetaminophen and Oxycodone Hydrochloride) Capsules, 500 mg/5 mg Roxane Laboratories Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 089775 ROXICET 5/500 (Acetaminophen and Oxycodone Hydrochloride) Tablets, 500 mg/5 mg Do.
ANDA 040100 LORTAB (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/10 mg UCB Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080.
ANDA 087722 LORTAB (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg Do.
ANDA 087757 CO-GESIC (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg Do.
ANDA 088831 PHRENILIN FORTE (Acetaminophen and Butalbital) Capsules, 650 mg/50 mg Valeant Pharmaceuticals North America LLC, 700 Route 202/206 North, Bridgewater, NJ 08807.
ANDA 040106 Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
ANDA 040143 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
ANDA 040144 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
ANDA 040155 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
ANDA 040157 Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040356 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg Do.
ANDA 040358 Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg Do.
ANDA 040513 Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg Do.
ANDA 040520 Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;7.5 mg/15 mL Do.
ANDA 089971 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
ANDA 089831 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
ANDA 040280 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
ANDA 040281 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040288 ZYDONE (Acetaminophen and Hydrocodone Bitartrate) Tablets, 400 mg/5 mg Do.
ZYDONE (Acetaminophen and Hydrocodone Bitartrate) Tablets, 400 mg/7.5 mg Do.
ZYDONE (Acetaminophen and Hydrocodone Bitartrate) Tablets, 400 mg/10 mg Do.
ANDA 040303 Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg Do.
ANDA 040341 PERCOCET (Acetaminophen and Oxycodone Hydrochloride) Tablets, 500 mg/7.5 mg Do.
PERCOCET (Acetaminophen and Oxycodone Hydrochloride) Tablets, 650 mg/10 mg Do.
ANDA 040371 Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mg Watson Laboratories, 311 Bonnie Circle, Corona, CA 92880.
ANDA 040094 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/10 mg Do.
ANDA 040234 Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg Do.
ANDA 040267 Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg Do.
ANDA 081079 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg Do.
ANDA 081080 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
ANDA 081083 Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040122 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040123 Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg Do.
ANDA 089883 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Do.
ANDA 040493 Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg Watson Laboratories Inc.-Florida, 2945 West Corporate Lakes Blvd., Suite B, Weston, FL 33331.
ANDA 040494 Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg Do.
ANDA 040495 Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg Do.
ANDA 040441 CODRIX (Acetaminophen and Codeine Phosphate) Tablets, 500 mg/30 mg Do.
ANDA 040447 CODRIX (Acetaminophen and Codeine Phosphate) Tablets, 500 mg/15 mg Do.
ANDA 040488 CODRIX (Acetaminophen and Codeine Phosphate) Tablets, 500 mg/60 mg Do.
ANDA 040261 Acetaminophen, Butalbital, and Caffeine Capsules, 500 mg/50 mg/40 mg West-Ward Pharmaceutical Corp., 435 Industrial Way West, Eatontown, NJ 07724.
ANDA 040336 Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg Do.
ANDA 040688 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Capsules, 356.4 mg/30 mg/16 mg WraSer Pharmaceuticals LLC, 121 Marketridge Dr., Ridgeland, MS 39157.


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.

[FR Doc. 2014-06801 Filed 3-26-14; 8:45 am]

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