Skip to Content

Notice

Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 The holders of these ANDAs have voluntarily requested that approval of these applications be withdrawn and have waived their opportunity for a hearing.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

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 17164announced 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.

Table 1—Applications for Which Withdrawal of Approval Has Been Requested

Application No.Drug product(s)Applicant or holder
ANDA 040199Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mgActavis Totowa LLC, 200 Elmora Ave., Elizabeth, NJ 07207.
ANDA 040748Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mgAmneal Pharmaceuticals, 85 Adams Ave., Hauppauge, NY 11788.
ANDA 040754Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg  Do.
ANDA 040757Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg  Do.
ANDA 040769Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040789Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg  Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mg  Do.
ANDA 040813Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg  Do.
ANDA 040729Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
ANDA 040304Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mgBarr Laboratories Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10956.
ANDA 040307Acetaminophen 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 040308Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040309Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg  Do.
ANDA 040701Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, 712.8 mg/60 mg/32 mgBoca Pharmacal LLC, 3550 Northwest 126th Ave., Coral Springs, FL 33065.
ANDA 090265Acetaminophen 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 mgCaraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Rd., Cranbury, NJ 08512.
ANDA 090380Acetaminophen 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 088898Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mgCentral Pharmaceuticals Inc., 110-128 East 3rd St., Seymour, IN 47274.
ANDA 090177Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg  Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mgCoastal Pharmaceuticals, 1240 Sugg Pkwy., Greenville, NC 27834.
ANDA 040289Acetaminophen and Oxycodone Capsules, 500 mg/5 mgDuramed Pharmaceuticals Inc., Sub Barr Laboratories Inc., 2 Quaker Rd., P.O. Box 2900, Pomona, NY 10970-0519.
ANDA 076202Acetaminophen and Pentazocine Hydrochloride Tablets, 650 mg/EQ 25 mg BaseGavis Pharmaceuticals, LLC, 400 Campus Dr., Somerset, NJ 08873.
ANDA 089696Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mgIvax Pharmaceuticals Inc., 140 Legrand Ave., Northvale, NJ 07647.
Start Printed Page 17165
ANDA 089907ALLAY (Acetaminophen and Hydrocodone Bitartrate) Capsules, 500 mg/5 mg  Do.
ANDA 088790TYLOX (Acetaminophen and Oxycodone Hydrochloride) Capsules, 500 mg/5 mgJanssen Research & Development, LLC, 920 U.S. Hwy. 202, P.O. Box 300, Raritan, NJ 08869.
ANDA 040084Acetaminophen 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 mgMallinckrodt Chemical Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
ANDA 040201Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg  Do.
ANDA 040257Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg  Do.
ANDA 087336LORCET-HD (Acetaminophen and Hydrocodone Bitartrate) Capsules, 500 mg/5 mg  Do.
ANDA 088956Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 088991BUCET (Acetaminophen and Butalbital) Capsules, 650 mg/50 mg  Do.
ANDA 089006Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 089160ANEXSIA (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg  Do.
ANDA 089405TENCON (Acetaminophen and Butalbital) Capsules, 650 mg/50 mg  Do.
ANDA 089725ANEXSIA 7.5/650 (Acetaminophen and Hydrocodone Bitartrate) Tablets, 650 mg/7.5 mg  Do.
ANDA 040418Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;7.5 mg/15 mL  Do.
ANDA 040468ANEXSIA (Acetaminophen and Hydrocodone Bitartrate) Tablets, 750 mg/10 mg  Do.
ANDA 040508Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;10 mg/15 mL  Do.
ANDA 040550Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg  Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mg  Do.
ANDA 040085ESGIC-PLUS (Acetaminophen, Butalbital, and Caffeine) Capsules, 500 mg/50 mg/40 mgMikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
ANDA 040496Acetaminophen, Butalbital, and Caffeine Tablets, 750 mg/50 mg/40 mg  Do.
ANDA 040676Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/10 mg  Do.
ANDA 040679Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/2.5 mg  Do.
ANDA 040687Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/5 mg  Do.
ANDA 040692Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/10 mg  Do.
ANDA 040698Acetaminophen and Oxycodone Hydrochloride Tablets, 400 mg/7.5 mg  Do.
ANDA 040849Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/5 mg  Do.
ANDA 081051Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL; 7.5 mg/15 mL  Do.
ANDA 081067Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 081223Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg  Do.
ANDA 089008Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 089451ESGIC-PLUS (Acetaminophen, Butalbital, and Caffeine) Tablets, 500 mg/50 mg/40 mg  Do.
ANDA 089689Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg  Do.
ANDA 089698Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg  Do.
Start Printed Page 17166
ANDA 089699Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg  Do.
ANDA 089988BUTAPAP (Acetaminophen and Butalbital) Tablets, 650 mg/50 mg  Do.
ANDA 089231Acetaminophen and Codeine Phosphate Tablets, 650 mg/30 mg  Do.
ANDA 089271Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
ANDA 089363Acetaminophen and Codeine Phosphate Tablets, 650 mg/60 mg  Do.
ANDA 040109Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Capsules, 356.4 mg/30 mg/16 mg  Do.
ANDA 040316Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets, 712.8 mg/60 mg/32 mg  Do.
ANDA 081068Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 081069Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 081070Acetaminophen and Hydrocodone Bitartrate Capsules, 500 mg/5 mg  Do.
ANDA 089557Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;5 mg/15 mL  Do.
ANDA 089697Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
ANDA 040883Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mgMirror Pharmaceuticals LLC, 140 New Dutch Lane, Fairfield, NJ 07004.
ANDA 040219Acetaminophen and Oxycodone Capsules, 500 mg/5 mgMutual Pharmaceutical Co. Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 040236Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040240Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg  Do.
ANDA 040061ROXILOX (Acetaminophen and Oxycodone Hydrochloride) Capsules, 500 mg/5 mgRoxane Laboratories Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 089775ROXICET 5/500 (Acetaminophen and Oxycodone Hydrochloride) Tablets, 500 mg/5 mg  Do.
ANDA 040100LORTAB (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/10 mgUCB Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080.
ANDA 087722LORTAB (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg  Do.
ANDA 087757CO-GESIC (Acetaminophen and Hydrocodone Bitartrate) Tablets, 500 mg/5 mg  Do.
ANDA 088831PHRENILIN FORTE (Acetaminophen and Butalbital) Capsules, 650 mg/50 mgValeant Pharmaceuticals North America LLC, 700 Route 202/206 North, Bridgewater, NJ 08807.
ANDA 040106Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mgVintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
ANDA 040143Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/10 mg  Do.
ANDA 040144Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg  Do.
ANDA 040155Acetaminophen and Hydrocodone Bitartrate Tablets, 650 mg/7.5 mg  Do.
ANDA 040157Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040356Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/10 mg  Do.
ANDA 040358Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg  Do.
ANDA 040513Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg  Do.
ANDA 040520Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 mL;7.5 mg/15 mL  Do.
ANDA 089971Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
ANDA 089831Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
Start Printed Page 17167
ANDA 040280Acetaminophen 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 040281Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040288ZYDONE (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 040303Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg  Do.
ANDA 040341PERCOCET (Acetaminophen and Oxycodone Hydrochloride) Tablets, 500 mg/7.5 mg  Do.
PERCOCET (Acetaminophen and Oxycodone Hydrochloride) Tablets, 650 mg/10 mg  Do.
ANDA 040371Acetaminophen and Oxycodone Hydrochloride Tablets, 500 mg/7.5 mg  Do.
Acetaminophen and Oxycodone Hydrochloride Tablets, 650 mg/10 mgWatson Laboratories, 311 Bonnie Circle, Corona, CA 92880.
ANDA 040094Acetaminophen 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 040234Acetaminophen and Oxycodone Hydrochloride Capsules, 500 mg/5 mg  Do.
ANDA 040267Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg  Do.
ANDA 081079Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/2.5 mg  Do.
ANDA 081080Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/7.5 mg  Do.
ANDA 081083Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040122Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040123Acetaminophen 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 089883Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mg  Do.
ANDA 040493Acetaminophen and Hydrocodone Bitartrate Tablets, 500 mg/5 mgWatson Laboratories Inc.—Florida, 2945 West Corporate Lakes Blvd., Suite B, Weston, FL 33331.
ANDA 040494Acetaminophen and Hydrocodone Bitartrate Tablets, 750 mg/7.5 mg  Do.
ANDA 040495Acetaminophen and Hydrocodone Bitartrate Tablets, 660 mg/10 mg  Do.
ANDA 040441CODRIX (Acetaminophen and Codeine Phosphate) Tablets, 500 mg/30 mg  Do.
ANDA 040447CODRIX (Acetaminophen and Codeine Phosphate) Tablets, 500 mg/15 mg  Do.
ANDA 040488CODRIX (Acetaminophen and Codeine Phosphate) Tablets, 500 mg/60 mg  Do.
ANDA 040261Acetaminophen, Butalbital, and Caffeine Capsules, 500 mg/50 mg/40 mgWest-Ward Pharmaceutical Corp., 435 Industrial Way West, Eatontown, NJ 07724.
Start Printed Page 17168
ANDA 040336Acetaminophen, Butalbital, and Caffeine Tablets, 500 mg/50 mg/40 mg  Do.
ANDA 040688Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Capsules, 356.4 mg/30 mg/16 mgWraSer 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)).

Start Signature

Dated: March 24, 2014.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

End Signature End Supplemental Information

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

BILLING CODE 4160-01-P