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Notice

Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 8 new drug applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene. The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.

DATES:

Effective March 10, 2014.

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FOR FURTHER INFORMATION CONTACT:

David Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Propoxyphene is an opioid pain relief medication marketed under brand names such as Darvon and Darvocet. In 1957, FDA approved NDAs 010996 and 010997 for propoxyphene hydrochloride (HCl), alone and in combination with other active ingredients, both of which are currently held by Xanodyne Pharmaceuticals, Inc. (Xanodyne).

In 2010, after receiving new clinical data showing that when propoxyphene is taken at therapeutic doses, the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, and other information including new epidemiological data, FDA concluded that the risks of propoxyphene outweigh its benefits as a pain reliever. In separate telephone conversations on November 18, 2010, FDA asked Xanodyne and the holders of marketed generic propoxyphene drug products to permit FDA to withdraw approval of their applications and to waive their opportunity for a hearing. In a separate notice published elsewhere in this issue of the Federal Register, FDA notifies other holders of ANDAs for pain medications containing propoxyphene of their opportunity to request a hearing if they wish to challenge the Agency's proposal to withdraw approval of their applications.

Xanodyne and manufacturers of generic propoxyphene products identified in table 1 have written to FDA asking the Agency to withdraw approval of their applications for propoxyphene-containing products and have waived their opportunity for a hearing. Some products approved under the applications identified in table 1 were discontinued in the past, before FDA's November 2010 determination that the risks of propoxyphene outweigh its benefits. Not included in table 1 are NDAs and ANDAs for which Federal Register notices were previously published announcing withdrawal of approval.

Table 1—Propoxyphene Drug Products for Which Application Holders Requested Withdrawal of Approval

Application No.DrugApplicant or holder
NDA 010996Darvon Compound (aspirin, caffeine, and propoxyphene HCl) Capsules, 389 milligrams (mg)/32.4 mg/32 mg Darvon Compound-65 (aspirin, caffeine, and propoxyphene HCl) Capsules, 389 mg/32.4 mg/65 mg Darvon with ASA (aspirin and propoxyphene HCl) Capsules, 325 mg/65 mgXanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071.
NDA 010997Darvon (propoxyphene HCl) Capsules, 32 mg and 65 mgDo.
NDA 016829Darvon-N with ASA (aspirin and propoxyphene napsylate) Capsules, 325 mg/100 mgAAIPharma Inc., 2320 Scientific Park Dr., Wilmington, NC 28405.
NDA 016844Darvocet (acetaminophen and propoxyphene HCl) Tablets, 325 mg/32.5 mgDo.
NDA 016861Darvon-N (propoxyphene napsylate) Suspension, 50 mg/5 millilitersDo.
NDA 016862Darvon-N (propoxyphene napsylate) Tablets, 100 mgDo.
NDA 016863Darvon-N with ASA (aspirin and propoxyphene napsylate) Tablets, 325 mg/100 mgDo.
NDA 017122Darvocet-N 50 (acetaminophen and propoxyphene napsylate) Tablets, 325 mg/50 mg Darvocet-N 100 (acetaminophen and propoxyphene napsylate) Tablets, 650 mg/100 mgXanodyne Pharmaceuticals, Inc.
ANDA 040139Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mgWatson Laboratories, Inc., 400 Interpace Pkwy., Parsippany, NJ 07054.
ANDA 040507Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mgVintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
ANDA 040569Propoxyphene HCl Capsules, 65 mgMylan Pharmaceuticals, 781 Chestnut Ridge Rd., Morgantown, WV 26505.
ANDA 040908Propoxyphene HCl Capsules, 65 mgVintage Pharmaceuticals.
ANDA 070115Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/50 mgMutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
ANDA 070116Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgDo.
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ANDA 070145Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgMylan Pharmaceuticals.
ANDA 070146Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgIVAX Pharmaceuticals, Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 070443Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgSandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
ANDA 070615Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgMutual Pharmaceutical Co., Inc.
ANDA 070771Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgDo.
ANDA 070775Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgDo.
ANDA 070910Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgActavis Elizabeth LLC, 200 Elmora Ave., Elizabeth, NJ 07202.
ANDA 072195Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgMylan Pharmaceuticals.
ANDA 074119Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgTeva Pharmaceuticals, 1090 Horsham Rd., North Wales, PA 19454.
ANDA 074843Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/50 mg and 650 mg/100 mgVintage Pharmaceuticals.
ANDA 075738Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgMallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO 63042.
ANDA 076429Darvocet A500 (acetaminophen and propoxyphene napsylate) Tablets, 500 mg/100 mgXanodyne Pharmaceuticals, Inc.
ANDA 076609Acetaminophen and Propoxyphene Napsylate Tablets, 650 mg/100 mgWatson Laboratories, Inc., 4955 Orange Dr., Fort Lauderdale, FL 33314.
ANDA 076743Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/100 mgCornerstone Therapeutics Inc., 1255 Crescent Green Dr., Cary, NC 27518.
ANDA 076750Acetaminophen and Propoxyphene Napsylate Tablets, 500 mg/100 mgDo.
ANDA 077196Acetaminophen and Propoxyphene Napsylate Tablets, 500 mg/100 mgWatson Laboratories, Inc.
ANDA 077677Acetaminophen and Propoxyphene Napsylate Tablets, 325 mg/50 mg and 650 mg/100 mgWockhardt USA LLC, 20 Waterview Blvd., Parsippany, NJ 07054.
ANDA 077821Acetaminophen and Propoxyphene Napsylate Tablets 650 mg/100 mgMirror Pharmaceuticals LLC, 140 New Dutch Ln., Fairfield, NJ 07004.
ANDA 080044Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/32.4 mg/65 mgSandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 080269Propoxyphene HCl Capsules, 65 mgPar Pharmaceuticals, Inc., 1 Ram Ridge Rd., Spring Valley, NJ 10977.
ANDA 080530Dolene (propoxyphene HCl) Capsules, 65 mgHeritage Pharmaceuticals Inc., 105 Fieldcrest Ave., Edison, NJ 08837.
ANDA 080783Propoxyphene HCl Capsules, 65 mgValeant Pharmaceuticals North America LLC, 700 Route 202/206 North, Bridgewater, NJ 08807.
ANDA 083101Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/32.4 mg/65 mgSandoz, Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
ANDA 083113Propoxyphene HCl Capsules, 65 mgPrivate Formulations Inc.
ANDA 083125Propoxyphene HCl Capsules, 65 mgSandoz, Inc.
ANDA 083185Propoxyphene HCl Capsules, 65 mgNexgen Pharma, Inc., 17802 Gillette Ave., Irvine, CA 92614.
ANDA 083186Propoxyphene HCl Capsules, 65 mgMutual Pharmaceutical Co. Inc.
ANDA 083464Propoxyphene HCl Capsules, 32 mgPrivate Formulations Inc.
ANDA 083501Propoxyphene HCl Capsules, 65 mgWest-Ward Pharmaceutical Corp., 435 Industrial Way West, Eatontown, NJ 07724.
ANDA 083528Propoxyphene HCl Capsules, 32 mgMylan Pharmaceuticals, 781 Chestnut Ridge Rd., Morgantown, WV 26505.
ANDA 083688Propoxyphene HCl Capsules, 65 mgSandoz Inc., 506 Carnegie Center, Princeton, NJ 08540.
ANDA 083689Acetaminophen and Propoxyphene HCl Tablets, 325 mg/32 mgMylan Pharmaceuticals.
ANDA 083870Propoxyphene HCl Capsules, 65 mgSandoz, Inc.
ANDA 083978Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mgMylan Pharmaceuticals.
ANDA 084014Propoxyphene HCl Capsules, 32 mgSandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 084999Wygesic (acetaminophen and propoxyphene HCl) Tablets, 650 mg/65 mgCaraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Dr., Detroit, MI 48202.
ANDA 086495Propoxyphene HCl Capsules, 65 mgSandoz, Inc.
ANDA 088615Propoxyphene HCl Capsules, 65 mgTeva Pharmaceuticals.
ANDA 089025Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/32.4 mg/65 mgDo.
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ANDA 089959Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65 mgSandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.

Therefore, under sections 505(e) and 505(j)(6) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e) and 355(j)(6)) and under authority delegated to the Director of the Center for Drug Evaluation and Research by the Commissioner of Food and Drugs, approval of the applications listed in table 1 and all amendments and supplements thereto, is withdrawn (see DATES). Introduction or delivery for introduction of these products into 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))).

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Dated: March 4, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-05063 Filed 3-7-14; 8:45 am]

BILLING CODE 4160-01-P