[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13308-13310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0198]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

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.

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
------------------------------------------------------------------------
                                                         Applicant or
        Application No.                  Drug               holder
------------------------------------------------------------------------
NDA 010996.....................  Darvon Compound      Xanodyne
                                  (aspirin,            Pharmaceuticals,
                                  caffeine, and        Inc., One
                                  propoxyphene HCl)    Riverfront Pl.,
                                  Capsules, 389        Newport, KY
                                  milligrams (mg)/     41071.
                                  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 mg.
NDA 010997.....................  Darvon               Do.
                                  (propoxyphene HCl)
                                  Capsules, 32 mg
                                  and 65 mg.
NDA 016829.....................  Darvon-N with ASA    AAIPharma Inc.,
                                  (aspirin and         2320 Scientific
                                  propoxyphene         Park Dr.,
                                  napsylate)           Wilmington, NC
                                  Capsules, 325 mg/    28405.
                                  100 mg.
NDA 016844.....................  Darvocet             Do.
                                  (acetaminophen and
                                  propoxyphene HCl)
                                  Tablets, 325 mg/
                                  32.5 mg.
NDA 016861.....................  Darvon-N             Do.
                                  (propoxyphene
                                  napsylate)
                                  Suspension, 50 mg/
                                  5 milliliters.
NDA 016862.....................  Darvon-N             Do.
                                  (propoxyphene
                                  napsylate)
                                  Tablets, 100 mg.
NDA 016863.....................  Darvon-N with ASA    Do.
                                  (aspirin and
                                  propoxyphene
                                  napsylate)
                                  Tablets, 325 mg/
                                  100 mg.
NDA 017122.....................  Darvocet-N 50        Xanodyne
                                  (acetaminophen and   Pharmaceuticals,
                                  propoxyphene         Inc.
                                  napsylate)
                                  Tablets, 325 mg/50
                                  mg.
                                 Darvocet-N 100
                                  (acetaminophen and
                                  propoxyphene
                                  napsylate)
                                  Tablets, 650 mg/
                                  100 mg.
ANDA 040139....................  Acetaminophen and    Watson
                                  Propoxyphene HCl     Laboratories,
                                  Tablets, 650 mg/65   Inc., 400
                                  mg.                  Interpace Pkwy.,
                                                       Parsippany, NJ
                                                       07054.
ANDA 040507....................  Acetaminophen and    Vintage
                                  Propoxyphene HCl     Pharmaceuticals,
                                  Tablets, 650 mg/65   150 Vintage Dr.,
                                  mg.                  Huntsville, AL
                                                       35811.
ANDA 040569....................  Propoxyphene HCl     Mylan
                                  Capsules, 65 mg.     Pharmaceuticals,
                                                       781 Chestnut
                                                       Ridge Rd.,
                                                       Morgantown, WV
                                                       26505.
ANDA 040908....................  Propoxyphene HCl     Vintage
                                  Capsules, 65 mg.     Pharmaceuticals.
ANDA 070115....................  Acetaminophen and    Mutual
                                  Propoxyphene         Pharmaceutical
                                  Napsylate Tablets,   Co., Inc., 1100
                                  325 mg/50 mg.        Orthodox St.,
                                                       Philadelphia, PA
                                                       19124.
ANDA 070116....................  Acetaminophen and    Do.
                                  Propoxyphene
                                  Napsylate Tablets,
                                  650 mg/100 mg.

[[Page 13309]]

 
ANDA 070145....................  Acetaminophen and    Mylan
                                  Propoxyphene         Pharmaceuticals.
                                  Napsylate Tablets,
                                  650 mg/100 mg.
ANDA 070146....................  Acetaminophen and    IVAX
                                  Propoxyphene         Pharmaceuticals,
                                  Napsylate Tablets,  Subsidiary of Teva
                                  650 mg/100 mg.       Pharmaceuticals
                                                       USA, 400 Chestnut
                                                       Ridge Rd.,
                                                       Woodcliff Lake,
                                                       NJ 07677.
ANDA 070443....................  Acetaminophen and    Sandoz Inc., 2555
                                  Propoxyphene         W. Midway Blvd.,
                                  Napsylate Tablets,   Broomfield, CO
                                  650 mg/100 mg.       80038.
ANDA 070615....................  Acetaminophen and    Mutual
                                  Propoxyphene         Pharmaceutical
                                  Napsylate Tablets,   Co., Inc.
                                  650 mg/100 mg.
ANDA 070771....................  Acetaminophen and    Do.
                                  Propoxyphene
                                  Napsylate Tablets,
                                  650 mg/100 mg.
ANDA 070775....................  Acetaminophen and    Do.
                                  Propoxyphene
                                  Napsylate Tablets,
                                  650 mg/100 mg.
ANDA 070910....................  Acetaminophen and    Actavis Elizabeth
                                  Propoxyphene         LLC, 200 Elmora
                                  Napsylate Tablets,   Ave., Elizabeth,
                                  650 mg/100 mg.       NJ 07202.
ANDA 072195....................  Acetaminophen and    Mylan
                                  Propoxyphene         Pharmaceuticals.
                                  Napsylate Tablets,
                                  650 mg/100 mg.
ANDA 074119....................  Acetaminophen and    Teva
                                  Propoxyphene         Pharmaceuticals,
                                  Napsylate Tablets,   1090 Horsham Rd.,
                                  650 mg/100 mg.       North Wales, PA
                                                       19454.
ANDA 074843....................  Acetaminophen and    Vintage
                                  Propoxyphene         Pharmaceuticals.
                                  Napsylate Tablets,
                                  325 mg/50 mg and
                                  650 mg/100 mg.
ANDA 075738....................  Acetaminophen and    Mallinckrodt Inc.,
                                  Propoxyphene         675 McDonnell
                                  Napsylate Tablets,   Blvd., Hazelwood,
                                  650 mg/100 mg.       MO 63042.
ANDA 076429....................  Darvocet A500        Xanodyne
                                  (acetaminophen and   Pharmaceuticals,
                                  propoxyphene         Inc.
                                  napsylate)
                                  Tablets, 500 mg/
                                  100 mg.
ANDA 076609....................  Acetaminophen and    Watson
                                  Propoxyphene         Laboratories,
                                  Napsylate Tablets,   Inc., 4955 Orange
                                  650 mg/100 mg.       Dr., Fort
                                                       Lauderdale, FL
                                                       33314.
ANDA 076743....................  Acetaminophen and    Cornerstone
                                  Propoxyphene         Therapeutics
                                  Napsylate Tablets,   Inc., 1255
                                  325 mg/100 mg.       Crescent Green
                                                       Dr., Cary, NC
                                                       27518.
ANDA 076750....................  Acetaminophen and    Do.
                                  Propoxyphene
                                  Napsylate Tablets,
                                  500 mg/100 mg.
ANDA 077196....................  Acetaminophen and    Watson
                                  Propoxyphene         Laboratories,
                                  Napsylate Tablets,   Inc.
                                  500 mg/100 mg.
ANDA 077677....................  Acetaminophen and    Wockhardt USA LLC,
                                  Propoxyphene         20 Waterview
                                  Napsylate Tablets,   Blvd.,
                                  325 mg/50 mg and     Parsippany, NJ
                                  650 mg/100 mg.       07054.
ANDA 077821....................  Acetaminophen and    Mirror
                                  Propoxyphene         Pharmaceuticals
                                  Napsylate Tablets    LLC, 140 New
                                  650 mg/100 mg.       Dutch Ln.,
                                                       Fairfield, NJ
                                                       07004.
ANDA 080044....................  Aspirin, Caffeine,   Sandoz, Inc., 4700
                                  and Propoxyphene     Sandoz Dr.,
                                  HCl Capsules, 389    Wilson, NC 27893.
                                  mg/32.4 mg/65 mg.
ANDA 080269....................  Propoxyphene HCl     Par
                                  Capsules, 65 mg.     Pharmaceuticals,
                                                       Inc., 1 Ram Ridge
                                                       Rd., Spring
                                                       Valley, NJ 10977.
ANDA 080530....................  Dolene               Heritage
                                  (propoxyphene HCl)   Pharmaceuticals
                                  Capsules, 65 mg.     Inc., 105
                                                       Fieldcrest Ave.,
                                                       Edison, NJ 08837.
ANDA 080783....................  Propoxyphene HCl     Valeant
                                  Capsules, 65 mg.     Pharmaceuticals
                                                       North America
                                                       LLC, 700 Route
                                                       202/206 North,
                                                       Bridgewater, NJ
                                                       08807.
ANDA 083101....................  Aspirin, Caffeine,   Sandoz, Inc., 2555
                                  and Propoxyphene     W. Midway Blvd.,
                                  HCl Capsules, 389    Broomfield, CO
                                  mg/32.4 mg/65 mg.    80038.
ANDA 083113....................  Propoxyphene HCl     Private
                                  Capsules, 65 mg.     Formulations Inc.
ANDA 083125....................  Propoxyphene HCl     Sandoz, Inc.
                                  Capsules, 65 mg.
ANDA 083185....................  Propoxyphene HCl     Nexgen Pharma,
                                  Capsules, 65 mg.     Inc., 17802
                                                       Gillette Ave.,
                                                       Irvine, CA 92614.
ANDA 083186....................  Propoxyphene HCl     Mutual
                                  Capsules, 65 mg.     Pharmaceutical
                                                       Co. Inc.
ANDA 083464....................  Propoxyphene HCl     Private
                                  Capsules, 32 mg.     Formulations Inc.
ANDA 083501....................  Propoxyphene HCl     West-Ward
                                  Capsules, 65 mg.     Pharmaceutical
                                                       Corp., 435
                                                       Industrial Way
                                                       West, Eatontown,
                                                       NJ 07724.
ANDA 083528....................  Propoxyphene HCl     Mylan
                                  Capsules, 32 mg.     Pharmaceuticals,
                                                       781 Chestnut
                                                       Ridge Rd.,
                                                       Morgantown, WV
                                                       26505.
ANDA 083688....................  Propoxyphene HCl     Sandoz Inc., 506
                                  Capsules, 65 mg.     Carnegie Center,
                                                       Princeton, NJ
                                                       08540.
ANDA 083689....................  Acetaminophen and    Mylan
                                  Propoxyphene HCl     Pharmaceuticals.
                                  Tablets, 325 mg/32
                                  mg.
ANDA 083870....................  Propoxyphene HCl     Sandoz, Inc.
                                  Capsules, 65 mg.
ANDA 083978....................  Acetaminophen and    Mylan
                                  Propoxyphene HCl     Pharmaceuticals.
                                  Tablets, 650 mg/65
                                  mg.
ANDA 084014....................  Propoxyphene HCl     Sandoz, Inc., 4700
                                  Capsules, 32 mg.     Sandoz Dr.,
                                                       Wilson, NC 27893.
ANDA 084999....................  Wygesic              Caraco
                                  (acetaminophen and   Pharmaceutical
                                  propoxyphene HCl)    Laboratories,
                                  Tablets, 650 mg/65   Ltd., 1150 Elijah
                                  mg.                  McCoy Dr.,
                                                       Detroit, MI
                                                       48202.
ANDA 086495....................  Propoxyphene HCl     Sandoz, Inc.
                                  Capsules, 65 mg.
ANDA 088615....................  Propoxyphene HCl     Teva
                                  Capsules, 65 mg.     Pharmaceuticals.
ANDA 089025....................  Aspirin, Caffeine,   Do.
                                  and Propoxyphene
                                  HCl Capsules, 389
                                  mg/32.4 mg/65 mg.

[[Page 13310]]

 
ANDA 089959....................  Acetaminophen and    Sandoz Inc., 2555
                                  Propoxyphene HCl     W. Midway Blvd.,
                                  Tablets, 650 mg/65   Broomfield, CO
                                  mg.                  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))).

    Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05063 Filed 3-7-14; 8:45 am]
BILLING CODE 4160-01-P