Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products, 13308-13310 [2014-05063]
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13308
Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
other than safety or effectiveness.
ANDAs that refer to ZEFAZONE
(cefmetazole sodium) Injection, EQ 1 g
base/vial and EQ 2 g base/vial, and
ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40
mg base/mL, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05059 Filed 3–7–14; 8:45 am]
BILLING CODE 4160–01–P
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.
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
SUMMARY:
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 propoxyphenecontaining 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.
Drug
Applicant or holder
NDA 010996 ........
Darvon 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 mg.
Darvon (propoxyphene HCl) Capsules, 32 mg and 65 mg ....
Darvon-N with ASA (aspirin and propoxyphene napsylate)
Capsules, 325 mg/100 mg.
Darvocet (acetaminophen and propoxyphene HCl) Tablets,
325 mg/32.5 mg.
Darvon-N (propoxyphene napsylate) Suspension, 50 mg/5
milliliters.
Darvon-N (propoxyphene napsylate) Tablets, 100 mg ...........
Darvon-N with ASA (aspirin and propoxyphene napsylate)
Tablets, 325 mg/100 mg.
Darvocet-N 50 (acetaminophen and propoxyphene
napsylate) Tablets, 325 mg/50 mg.
Darvocet-N 100 (acetaminophen and propoxyphene
napsylate) Tablets, 650 mg/100 mg.
Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65
mg.
Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65
mg.
Propoxyphene HCl Capsules, 65 mg .....................................
Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071.
NDA 010997 ........
NDA 016829 ........
NDA 016844 ........
NDA 016861 ........
NDA 016862 ........
NDA 016863 ........
NDA 017122 ........
emcdonald on DSK67QTVN1PROD with NOTICES
ANDA 040139 ......
ANDA 040507 ......
ANDA 040569 ......
ANDA 040908 ......
ANDA 070115 ......
ANDA 070116 ......
VerDate Mar<15>2010
Propoxyphene HCl Capsules, 65 mg .....................................
Acetaminophen and Propoxyphene Napsylate Tablets, 325
mg/50 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
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Do.
AAIPharma Inc., 2320 Scientific Park Dr., Wilmington, NC
28405.
Do.
Do.
Do.
Do.
Xanodyne Pharmaceuticals, Inc.
Watson Laboratories, Inc., 400 Interpace Pkwy., Parsippany,
NJ 07054.
Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL
35811.
Mylan Pharmaceuticals, 781 Chestnut Ridge Rd., Morgantown, WV 26505.
Vintage Pharmaceuticals.
Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
Do.
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Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
13309
TABLE 1—PROPOXYPHENE DRUG PRODUCTS FOR WHICH APPLICATION HOLDERS REQUESTED WITHDRAWAL OF
APPROVAL—Continued
Application No.
Drug
ANDA 070145 ......
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
ANDA 070146 ......
ANDA 070443 ......
Applicant or holder
ANDA 080269 ......
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 325
mg/50 mg and 650 mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Darvocet A500 (acetaminophen and propoxyphene
napsylate) Tablets, 500 mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 650
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 325
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 500
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 500
mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets, 325
mg/50 mg and 650 mg/100 mg.
Acetaminophen and Propoxyphene Napsylate Tablets 650
mg/100 mg.
Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/
32.4 mg/65 mg.
Propoxyphene HCl Capsules, 65 mg .....................................
ANDA 080530 ......
Dolene (propoxyphene HCl) Capsules, 65 mg .......................
ANDA 080783 ......
Propoxyphene HCl Capsules, 65 mg .....................................
ANDA 083101 ......
Aspirin, Caffeine, and Propoxyphene
32.4 mg/65 mg.
Propoxyphene HCl Capsules, 65 mg
Propoxyphene HCl Capsules, 65 mg
Propoxyphene HCl Capsules, 65 mg
Propoxyphene HCl Capsules, 65 mg
Propoxyphene HCl Capsules, 32 mg
Propoxyphene HCl Capsules, 65 mg
ANDA 070615 ......
ANDA 070771 ......
ANDA 070775 ......
ANDA 070910 ......
ANDA 072195 ......
ANDA 074119 ......
ANDA 074843 ......
ANDA 075738 ......
ANDA 076429 ......
ANDA 076609 ......
ANDA 076743 ......
ANDA 076750 ......
ANDA 077196 ......
ANDA 077677 ......
ANDA 077821 ......
ANDA 080044 ......
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
083113
083125
083185
083186
083464
083501
......
......
......
......
......
......
HCl Capsules, 389 mg/
.....................................
.....................................
.....................................
.....................................
.....................................
.....................................
Propoxyphene HCl Capsules, 32 mg .....................................
ANDA 083688 ......
ANDA 083689 ......
emcdonald on DSK67QTVN1PROD with NOTICES
ANDA 083528 ......
Propoxyphene HCl Capsules, 65 mg .....................................
Acetaminophen and Propoxyphene HCl Tablets, 325 mg/32
mg.
Propoxyphene HCl Capsules, 65 mg .....................................
Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65
mg.
Propoxyphene HCl Capsules, 32 mg .....................................
Wygesic (acetaminophen and propoxyphene HCl) Tablets,
650 mg/65 mg.
Propoxyphene HCl Capsules, 65 mg .....................................
Propoxyphene HCl Capsules, 65 mg .....................................
Aspirin, Caffeine, and Propoxyphene HCl Capsules, 389 mg/
32.4 mg/65 mg.
ANDA 083870 ......
ANDA 083978 ......
ANDA 084014 ......
ANDA 084999 ......
ANDA 086495 ......
ANDA 088615 ......
ANDA 089025 ......
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Mylan Pharmaceuticals.
IVAX Pharmaceuticals,
Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut
Ridge Rd., Woodcliff Lake, NJ 07677.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
Mutual Pharmaceutical Co., Inc.
Do.
Do.
Actavis Elizabeth LLC, 200 Elmora Ave., Elizabeth, NJ
07202.
Mylan Pharmaceuticals.
Teva Pharmaceuticals, 1090 Horsham Rd., North Wales, PA
19454.
Vintage Pharmaceuticals.
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
63042.
Xanodyne Pharmaceuticals, Inc.
Watson Laboratories, Inc., 4955 Orange Dr., Fort Lauderdale, FL 33314.
Cornerstone Therapeutics Inc., 1255 Crescent Green Dr.,
Cary, NC 27518.
Do.
Watson Laboratories, Inc.
Wockhardt USA LLC, 20 Waterview Blvd., Parsippany, NJ
07054.
Mirror Pharmaceuticals LLC, 140 New Dutch Ln., Fairfield,
NJ 07004.
Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
Par Pharmaceuticals, Inc., 1 Ram Ridge Rd., Spring Valley,
NJ 10977.
Heritage Pharmaceuticals Inc., 105 Fieldcrest Ave., Edison,
NJ 08837.
Valeant Pharmaceuticals North America LLC, 700 Route
202/206 North, Bridgewater, NJ 08807.
Sandoz, Inc., 2555 W. Midway Blvd., Broomfield, CO 80038.
Private Formulations Inc.
Sandoz, Inc.
Nexgen Pharma, Inc., 17802 Gillette Ave., Irvine, CA 92614.
Mutual Pharmaceutical Co. Inc.
Private Formulations Inc.
West-Ward Pharmaceutical Corp., 435 Industrial Way West,
Eatontown, NJ 07724.
Mylan Pharmaceuticals, 781 Chestnut Ridge Rd., Morgantown, WV 26505.
Sandoz Inc., 506 Carnegie Center, Princeton, NJ 08540.
Mylan Pharmaceuticals.
Sandoz, Inc.
Mylan Pharmaceuticals.
Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah
McCoy Dr., Detroit, MI 48202.
Sandoz, Inc.
Teva Pharmaceuticals.
Do.
E:\FR\FM\10MRN1.SGM
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13310
Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
TABLE 1—PROPOXYPHENE DRUG PRODUCTS FOR WHICH APPLICATION HOLDERS REQUESTED WITHDRAWAL OF
APPROVAL—Continued
Application No.
Drug
Applicant or holder
ANDA 089959 ......
Acetaminophen and Propoxyphene HCl Tablets, 650 mg/65
mg.
Sandoz 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))).
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0199]
MK Laboratories, Inc., et al.; Proposal
To Withdraw Approval of Three
Abbreviated New Drug Applications for
Propoxyphene Products; Opportunity
for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research (CDER) is
proposing to withdraw approval of three
abbreviated new drug applications
(ANDAs) for propoxyphene drug
products from multiple sources and is
announcing an opportunity for holders
of those ANDAs to request a hearing on
this proposal.
DATES: Submit written requests for a
hearing by April 9, 2014; submit data
and information in support of the
hearing request by May 9, 2014.
ADDRESSES: Requests for a hearing,
supporting data, and other comments
are to be identified with Docket No.
FDA–2014–N–0199 and submitted to
the Division of Dockets Management,
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
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 first approved by FDA in
1957. It has been marketed as a single
active ingredient drug product and in
combination with other active
ingredients such as acetaminophen. It
has been marketed under brand names
SUMMARY:
such as Darvon and Darvocet and in
generic forms.
After receiving clinical data and other
information showing that propoxyphene
puts patients at risk of potentially
serious and even fatal heart rhythm
abnormalities, FDA determined that the
risks of propoxyphene outweigh its
benefits. On November 18, 2010, FDA
asked Xanodyne Pharmaceuticals, Inc.
(Xanodyne), the maker of Darvon and
Darvocet, and manufacturers of then
marketed generic propoxyphene drug
products to voluntarily withdraw their
products from the U.S. market. In a
separate notice published elsewhere in
this issue of the Federal Register, FDA
is withdrawing approval of 8 NDAs and
46 ANDAs from multiple sources,
whose application holders have agreed
in writing to permit FDA to withdraw
approval of the applications and have
waived their opportunity for a hearing.
Although the holders of the approved
applications listed in Table 1 are
believed to have discontinued
marketing these products prior to
November 2010, FDA has not received
correspondence from these application
holders requesting that the Agency
withdraw approval of the identified
applications. Hence, in accordance with
section 505(e) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(e)), we hereby notify the application
holders listed in Table 1 of their
opportunity to request a hearing on
CDER’s proposal to withdraw approval
of the listed applications.
TABLE 1—PROPOXYPHENE DRUG PRODUCT APPLICATIONS FOR WHICH FDA PROPOSES TO WITHDRAW APPROVAL
Application No.
Drug
Applicant or holder
ANDA 083544 ....................................................
Kesso-Gesic (propoxyphene hydrochloride
(HCl)) Capsules, 65 milligrams (mg).
Propoxyphene HCl Capsules, 65 mg ...............
Compound 65 (aspirin, caffeine, and
propoxyphene HCl) Capsules, 389 mg/32.4
mg/65 mg.
MK Laboratories Inc., 424 Grasmere Ave.,
Fairfield, CT 06430.
Whiteworth Towne Paulsen Inc.
Alra Labs, 3850 Clearview Ct., Gurnee, IL
60031.
FD&C Act required that drugs be shown
to be effective as well as safe. To
implement the 1962 amendments, FDA
initiated the Drug Efficacy Study
Implementation (DESI) review to
evaluate the effectiveness of drugs that
had been previously approved on safety
grounds alone. In its DESI review of
propoxyphene HCl; propoxyphene HCl
with aspirin; and propoxyphene HCl
with aspirin, phenacetin, and caffeine,
FDA concluded that these drugs were
effective for the relief of mild to
moderate pain (34 FR 6264, April 8,
1969).
emcdonald on DSK67QTVN1PROD with NOTICES
ANDA 084551 ....................................................
ANDA 084553 ....................................................
I. Safety Concern
NDAs 010996 and 010997 for
propoxyphene HCl alone and in
combination with aspirin and caffeine,
both held by Xanodyne, were initially
approved in 1957 solely on the basis of
safety. The 1962 amendments to the
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]]>Agencies
[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13308-13310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05063]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
