Determination That OXYTOCIN in 5% Dextrose Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 22529 [2015-09299]
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–P–1896]
Determination That OXYTOCIN in 5%
Dextrose Injection Products 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Withdrawn From Sale for Reasons of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 or Agency) has
determined that OXYTOCIN 5 United
States Pharmacopeia (USP) Units in
Dextrose 5% (oxytocin), injectable,
injection, 5 USP Units in 500 milliliters
(mL), (1 USP Unit/100 mL); OXYTOCIN
10 USP Units in Dextrose 5%
(oxytocin), injectable, injection, 10 USP
Units in 500 mL, (2 USP Units/100 mL);
OXYTOCIN 10 USP Units in Dextrose
5% (oxytocin), injectable, injection, 10
USP Units in 1000 mL, (1 USP Unit/100
mL); and OXYTOCIN 20 USP Units in
Dextrose 5% (oxytocin), injectable,
injection, 20 USP Units in 1000 mL, (2
USP Units/100 mL), (hereinafter ‘‘these
oxytocin drug products’’) were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve an abbreviated new drug
application (ANDA) for these oxytocin
drug products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Robin Fastenau, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 240–
402–4510.
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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
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.
These oxytocin drug products are the
subject of NDA 019–185, held by Abbott
Laboratories, and initially approved on
March 29, 1985. These oxytocin drug
products are indicated for the initiation
or improvement of uterine contractions.
In a December 26, 1995, letter, Abbott
Laboratories notified FDA that these
oxytocin drug products were being
discontinued and requested withdrawal
of NDA 019–185. In the Federal
Register of March 27, 1996 (61 FR
13506), FDA announced that it was
withdrawing approval of NDA 019–185,
effective April 26, 1996. FDA has moved
these oxytocin drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
TechReg Services, Inc. (TechReg),
submitted a citizen petition dated
November 12, 2014 (Docket No. FDA–
2014–P–1896), under 21 CFR 10.30,
requesting that the Agency determine
whether Oxytocin in Dextrose 5%,
injection, available as strengths 5, 10,
and 20 units under Abbott NDA 019–
185, were withdrawn from sale for
reasons of safety or effectiveness.
Although the citizen petition did not
specify the concentrations of the three
strengths associated with NDA 019–185,
we have considered whether any of
these oxytocin drug products approved
under NDA 019–185 were withdrawn
for safety or effectiveness reasons.
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 these oxytocin drug
products were not withdrawn for
reasons of safety or effectiveness.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
22529
TechReg has identified no data or other
information suggesting that these
oxytocin drug products were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
these oxytocin drug products 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 oxytocin drug
products were withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list these oxytocin drug
products 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
other than safety or effectiveness.
ANDAs that refer to these oxytocin drug
products may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. FDA has
determined that labeling for these
oxytocin drug products should be
revised to meet current standards and
will advise ANDA applicants how to
submit such labeling.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09299 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1163]
Providing Regulatory Submissions in
Electronic and Non-Electronic
Format—Promotional Labeling and
Advertising Materials for Human
Prescription Drugs, Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic and NonElectronic Format—Promotional
Labeling and Advertising Materials for
Human Prescription Drugs.’’ This draft
guidance explains how manufacturers,
packers, and distributors (firms) that
may either be the applicant or acting on
SUMMARY:
E:\FR\FM\22APN1.SGM
22APN1
]]>Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09299]
[[Page 22529]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-P-1896]
Determination That OXYTOCIN in 5% Dextrose Injection Products
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 or Agency) has
determined that OXYTOCIN 5 United States Pharmacopeia (USP) Units in
Dextrose 5% (oxytocin), injectable, injection, 5 USP Units in 500
milliliters (mL), (1 USP Unit/100 mL); OXYTOCIN 10 USP Units in
Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 500 mL,
(2 USP Units/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin),
injectable, injection, 10 USP Units in 1000 mL, (1 USP Unit/100 mL);
and OXYTOCIN 20 USP Units in Dextrose 5% (oxytocin), injectable,
injection, 20 USP Units in 1000 mL, (2 USP Units/100 mL), (hereinafter
``these oxytocin drug products'') were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve an abbreviated new drug application (ANDA) for these
oxytocin drug products, if all other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-
402-4510.
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.
These oxytocin drug products are the subject of NDA 019-185, held
by Abbott Laboratories, and initially approved on March 29, 1985. These
oxytocin drug products are indicated for the initiation or improvement
of uterine contractions. In a December 26, 1995, letter, Abbott
Laboratories notified FDA that these oxytocin drug products were being
discontinued and requested withdrawal of NDA 019-185. In the Federal
Register of March 27, 1996 (61 FR 13506), FDA announced that it was
withdrawing approval of NDA 019-185, effective April 26, 1996. FDA has
moved these oxytocin drug products to the ``Discontinued Drug Product
List'' section of the Orange Book.
TechReg Services, Inc. (TechReg), submitted a citizen petition
dated November 12, 2014 (Docket No. FDA-2014-P-1896), under 21 CFR
10.30, requesting that the Agency determine whether Oxytocin in
Dextrose 5%, injection, available as strengths 5, 10, and 20 units
under Abbott NDA 019-185, were withdrawn from sale for reasons of
safety or effectiveness. Although the citizen petition did not specify
the concentrations of the three strengths associated with NDA 019-185,
we have considered whether any of these oxytocin drug products approved
under NDA 019-185 were withdrawn for safety or effectiveness reasons.
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 these oxytocin drug products were
not withdrawn for reasons of safety or effectiveness. TechReg has
identified no data or other information suggesting that these oxytocin
drug products were withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of these oxytocin drug products 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 oxytocin drug products were withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list these oxytocin drug
products 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 other than safety or effectiveness. ANDAs that refer to
these oxytocin drug products may be approved by the Agency as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. FDA has determined that labeling for these oxytocin drug
products should be revised to meet current standards and will advise
ANDA applicants how to submit such labeling.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09299 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P
