[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.
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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