Determination That ZEFAZONE (Cefmetazole Sodium) Injection, Equivalent to 1 Gram Base/Vial and Equivalent to 2 Gram Base/Vial, and ZEFAZONE (Cefmetazole Sodium) Intravenous Solution, Equivalent to 20 Milligrams Base/Milliliter and Equivalent to 40 Milligrams Base/Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 13307-13308 [2014-05059]
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Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
Dated: March 5, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–05104 Filed 3–7–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0768]
Determination That ZEFAZONE
(Cefmetazole Sodium) Injection,
Equivalent to 1 Gram Base/Vial and
Equivalent to 2 Gram Base/Vial, and
ZEFAZONE (Cefmetazole Sodium)
Intravenous Solution, Equivalent to 20
Milligrams Base/Milliliter and
Equivalent to 40 Milligrams Base/
Milliliter, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that ZEFAZONE (cefmetazole sodium)
Injection, equivalent to (EQ) 1 gram (g)
base/vial and EQ 2 g base/vial, and
ZEFAZONE (cefmetazole sodium)
Intravenous (IV) Solution, EQ 20
milligrams (mg) base/milliliter (mL) and
EQ 40 mg base/mL, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
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 40 mg base/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kathy Schreier, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6246,
Silver Spring, MD 20993–0002, 301–
796–3432.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:00 Mar 07, 2014
Jkt 232001
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the Orange
Book. Under FDA regulations, drugs are
removed from the list if the Agency
withdraws or suspends approval of the
drug’s NDA or ANDA for reasons of
safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ZEFAZONE (cefmetazole sodium)
Injection, EQ 1 g base/vial and EQ 2 g
base/vial, is the subject of NDA 50–637,
held by Pharmacia & Upjohn, Inc.,
which was initially approved on
December 11, 1989; and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
is the subject of NDA 50–683, held by
Pharmacia & Upjohn, Inc., which was
initially approved on December 29,
1992. ZEFAZONE is a semisynthetic
cephem antibiotic that is indicated for
treatment of urinary tract infections,
lower respiratory tract infections, skin
and skin structure infections, and intraabdominal infections.
In a letter dated August 1, 2000,
Pharmacia & Upjohn, Inc., notified FDA
that 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, were no longer
being marketed and requested
withdrawal of NDA 50–637 and NDA
50–683. FDA moved the drug products
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book and, in the
Federal Register of August 16, 2001 (66
FR 43017), announced that it was
withdrawing approval of NDA 50–637
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
13307
and NDA 50–683 effective September
17, 2001.
Salus Pharma LLC submitted a citizen
petition dated June 17, 2013 (Docket No.
FDA–2013–P–0768), under 21 CFR
10.30, requesting that the Agency
determine whether ZEFAZONE
(cefmetazole sodium) Injection, EQ 1 g
base/vial and EQ 2 g base/vial, was
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not request that we
determine whether ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
approved under NDA 50–683, was
withdrawn for safety or effectiveness,
that product also has been discontinued.
On our own initiative, we have also
determined whether ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
was withdrawn for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that 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,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that 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, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
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, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that these products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list 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, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
E:\FR\FM\10MRN1.SGM
10MRN1
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.
18:00 Mar 07, 2014
Jkt 232001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\10MRN1.SGM
10MRN1
]]>Agencies
[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13307-13308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0768]
Determination That ZEFAZONE (Cefmetazole Sodium) Injection,
Equivalent to 1 Gram Base/Vial and Equivalent to 2 Gram Base/Vial, and
ZEFAZONE (Cefmetazole Sodium) Intravenous Solution, Equivalent to 20
Milligrams Base/Milliliter and Equivalent to 40 Milligrams Base/
Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that
ZEFAZONE (cefmetazole sodium) Injection, equivalent to (EQ) 1 gram (g)
base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium)
Intravenous (IV) Solution, EQ 20 milligrams (mg) base/milliliter (mL)
and EQ 40 mg base/mL, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for 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 40 mg base/mL,
if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kathy Schreier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 301-
796-3432.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the Orange Book.
Under FDA regulations, drugs are removed from the list if the Agency
withdraws or suspends approval of the drug's NDA or ANDA for reasons of
safety or effectiveness or if FDA determines that the listed drug was
withdrawn from sale for reasons of safety or effectiveness (21 CFR
314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2
g base/vial, is the subject of NDA 50-637, held by Pharmacia & Upjohn,
Inc., which was initially approved on December 11, 1989; and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, is the subject of NDA 50-683, held by Pharmacia & Upjohn, Inc.,
which was initially approved on December 29, 1992. ZEFAZONE is a
semisynthetic cephem antibiotic that is indicated for treatment of
urinary tract infections, lower respiratory tract infections, skin and
skin structure infections, and intra-abdominal infections.
In a letter dated August 1, 2000, Pharmacia & Upjohn, Inc.,
notified FDA that 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, were no longer being
marketed and requested withdrawal of NDA 50-637 and NDA 50-683. FDA
moved the drug products to the ``Discontinued Drug Product List''
section of the Orange Book and, in the Federal Register of August 16,
2001 (66 FR 43017), announced that it was withdrawing approval of NDA
50-637 and NDA 50-683 effective September 17, 2001.
Salus Pharma LLC submitted a citizen petition dated June 17, 2013
(Docket No. FDA-2013-P-0768), under 21 CFR 10.30, requesting that the
Agency determine whether ZEFAZONE (cefmetazole sodium) Injection, EQ 1
g base/vial and EQ 2 g base/vial, was withdrawn from sale for reasons
of safety or effectiveness. Although the citizen petition did not
request that we determine whether ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, approved under NDA 50-
683, was withdrawn for safety or effectiveness, that product also has
been discontinued. On our own initiative, we have also determined
whether ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg base/mL and
EQ 40 mg base/mL, was withdrawn for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that 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, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that 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, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
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, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
these products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list 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, in the ``Discontinued Drug Product List'' section of the Orange
Book. The ``Discontinued Drug Product List'' delineates, among other
items, drug products that have been discontinued from marketing for
reasons
[[Page 13308]]
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
