Determination That DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 42512-42513 [2018-18045]
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42512
Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number
of respondents
Activity
Total annual
disclosures
Average
burden per
disclosure
Total hours
Format labeling in accordance with § 201.66(c) and (d) for
new sunscreen SKUs .......................................................
Request for Drug Facts exemption or deferral § 201.66(e)
20
1
3
0.125
60
0.125
12
24
720
3
Total ..............................................................................
........................
........................
........................
........................
723
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We note that these estimates may be
adjusted in the future development of
an upcoming rulemaking on over-thecounter sunscreen products (RIN 0910–
AA01). FDA intends to amend this
information collection and/or seek
approval of additional information
collections, as appropriate, concurrent
with this rulemaking.
Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18073 Filed 8–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–P–1335 and FDA–
2018–P–1361]
Determination That DITROPAN XL
(Oxybutynin Chloride) Extended
Release Tablets, 15 Milligrams, 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Not Withdrawn From Sale for Reasons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 DITROPAN XL
(oxybutynin chloride) Extended Release
Tablets, 15 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for DITROPAN
XL (oxybutynin chloride) Extended
Release Tablets, 15 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Glen
Cheng, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6210, Silver Spring,
MD 20993–0002, 301–796–1494.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Number of
disclosures
per
respondent
VerDate Sep<11>2014
16:34 Aug 21, 2018
Jkt 244001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 5 mg, 10 mg,
and 15 mg, are the subject of NDA
020897, held by Janssen
Pharmaceuticals Inc., and initially
approved on December 16, 1998.
DITROPAN XL is indicated for the
treatment of overactive bladder with
symptoms of urge urinary incontinence,
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
urgency, and frequency, and for the
treatment of pediatric patients aged 6
years and older with symptoms of
detrusor overactivity associated with a
neurological condition (e.g., spina
bifida).
In a letter dated December 14, 2017,
Janssen Pharmaceuticals Inc. notified
FDA that DITROPAN XL (oxybutynin
chloride) Extended Release Tablets, 15
mg, were being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Although
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 5 mg and 10
mg, were also previously listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book, they are
now listed in the ‘‘Prescription Drug
Product List’’ section of the Orange
Book.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
March 30, 2018 (Docket No. FDA–2018–
P–1335), and Ajanta Pharma Limited
submitted a citizen petition dated April
2, 2018 (Docket No. FDA–2018–P–
1361), under 21 CFR 10.30, requesting
that the Agency determine whether
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 5 mg, 10 mg,
and 15 mg, were withdrawn from sale
for reasons of safety or effectiveness.
As noted, DITROPAN XL (oxybutynin
chloride) Extended Release Tablets, 5
mg and 10 mg, are no longer listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book, and
therefore we need not determine
whether they were withdrawn from sale
for reasons of safety or effectiveness.
With regard to DITROPAN XL
(oxybutynin chloride) Extended Release
Tablets, 15 mg, 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
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 15 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. The petitioners
have identified no data or other
information suggesting that this drug
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
DITROPAN XL (oxybutynin chloride)
Extended Release Tablets, 15 mg, 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 this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list DITROPAN XL
(oxybutynin chloride) Extended Release
Tablets, 15 mg, 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 DITROPAN XL
(oxybutynin chloride) Extended Release
Tablets, 15 mg, 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 this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18045 Filed 8–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2381]
The Food and Drug Administration’s
Comprehensive, Multi-Year Nutrition
Innovation Strategy; Extension of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; extension of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notice of a public meeting and request
for comments, published in the Federal
Register of June 27, 2018. The notice
announced a public meeting entitled
‘‘FDA’s Comprehensive, Multi-Year
Nutrition Innovation Strategy’’ and
invited interested parties to provide
information on specific topics related to
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:34 Aug 21, 2018
Jkt 244001
FDA’s Nutrition Innovation Strategy.
We are extending the comment period
to give interested parties more time to
comment.
DATES: FDA is extending the comment
period on the notice and its request for
comment, published in the Federal
Register of June 27, 2018 (83 FR 30180).
Submit either electronic or written
comments by October 11, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 11,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time,
October 11, 2018. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
42513
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–2381 for ‘‘The Food and Drug
Administration’s Comprehensive, MultiYear Nutrition Innovation Strategy;
Public Meeting; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42512-42513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18045]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-P-1335 and FDA-2018-P-1361]
Determination That DITROPAN XL (Oxybutynin Chloride) Extended
Release Tablets, 15 Milligrams, 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 DITROPAN XL (oxybutynin chloride) Extended Release
Tablets, 15 milligrams (mg), were not withdrawn from sale for reasons
of safety or effectiveness. This determination will allow FDA to
approve abbreviated new drug applications (ANDAs) for DITROPAN XL
(oxybutynin chloride) Extended Release Tablets, 15 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Glen Cheng, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-796-1494.
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.
DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5 mg,
10 mg, and 15 mg, are the subject of NDA 020897, held by Janssen
Pharmaceuticals Inc., and initially approved on December 16, 1998.
DITROPAN XL is indicated for the treatment of overactive bladder with
symptoms of urge urinary incontinence, urgency, and frequency, and for
the treatment of pediatric patients aged 6 years and older with
symptoms of detrusor overactivity associated with a neurological
condition (e.g., spina bifida).
In a letter dated December 14, 2017, Janssen Pharmaceuticals Inc.
notified FDA that DITROPAN XL (oxybutynin chloride) Extended Release
Tablets, 15 mg, were being discontinued, and FDA moved the drug product
to the ``Discontinued Drug Product List'' section of the Orange Book.
Although DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5
mg and 10 mg, were also previously listed in the ``Discontinued Drug
Product List'' section of the Orange Book, they are now listed in the
``Prescription Drug Product List'' section of the Orange Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
March 30, 2018 (Docket No. FDA-2018-P-1335), and Ajanta Pharma Limited
submitted a citizen petition dated April 2, 2018 (Docket No. FDA-2018-
P-1361), under 21 CFR 10.30, requesting that the Agency determine
whether DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 5
mg, 10 mg, and 15 mg, were withdrawn from sale for reasons of safety or
effectiveness.
As noted, DITROPAN XL (oxybutynin chloride) Extended Release
Tablets, 5 mg and 10 mg, are no longer listed in the ``Discontinued
Drug Product List'' section of the Orange Book, and therefore we need
not determine whether they were withdrawn from sale for reasons of
safety or effectiveness.
With regard to DITROPAN XL (oxybutynin chloride) Extended Release
Tablets, 15 mg, 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 DITROPAN XL (oxybutynin
chloride) Extended Release Tablets, 15 mg, were not withdrawn from sale
for reasons of safety or effectiveness. The petitioners have identified
no data or other information suggesting that this drug
[[Page 42513]]
product was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, 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 this drug product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list DITROPAN XL
(oxybutynin chloride) Extended Release Tablets, 15 mg, 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 DITROPAN XL
(oxybutynin chloride) Extended Release Tablets, 15 mg, 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 this drug product should be revised to meet current standards, the
Agency will advise ANDA applicants to submit such labeling.
Dated: August 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18045 Filed 8-21-18; 8:45 am]
BILLING CODE 4164-01-P
