83 FR 42512 - Determination That DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 163 (August 22, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 163 (August 22, 2018)
| Page Range | 42512-42513 | |
| FR Document | 2018-18045 |
[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)] [Notices] [Pages 42512-42513] From the Federal Register Online [www.thefederalregister.org] [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FDA-2018-P-1361] Determination That DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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or Agency) has determined that DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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
![42512 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number disclosures Total annual
Activity burden per Total hours
of respondents per disclosures disclosure
respondent
Format labeling in accordance with § 201.66(c) and (d) for
new sunscreen SKUs ....................................................... 20 3 60 12 720
Request for Drug Facts exemption or deferral § 201.66(e) 1 0.125 0.125 24 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 Competition and Patent Term urgency, and frequency, and for the
adjusted in the future development of Restoration Act of 1984 (Pub. L. 98–417) treatment of pediatric patients aged 6
an upcoming rulemaking on over-the- (the 1984 amendments), which years and older with symptoms of
counter sunscreen products (RIN 0910– authorized the approval of duplicate detrusor overactivity associated with a
AA01). FDA intends to amend this versions of drug products under an neurological condition (e.g., spina
information collection and/or seek ANDA procedure. ANDA applicants bifida).
approval of additional information must, with certain exceptions, show that In a letter dated December 14, 2017,
collections, as appropriate, concurrent the drug for which they are seeking Janssen Pharmaceuticals Inc. notified
with this rulemaking. approval contains the same active FDA that DITROPAN XL (oxybutynin
ingredient in the same strength and chloride) Extended Release Tablets, 15
Dated: August 16, 2018.
dosage form as the ‘‘listed drug,’’ which mg, were being discontinued, and FDA
Leslie Kux,
is a version of the drug that was moved the drug product to the
Associate Commissioner for Policy. previously approved. ANDA applicants ‘‘Discontinued Drug Product List’’
[FR Doc. 2018–18073 Filed 8–21–18; 8:45 am] do not have to repeat the extensive section of the Orange Book. Although
BILLING CODE 4164–01–P clinical testing otherwise necessary to DITROPAN XL (oxybutynin chloride)
gain approval of a new drug application Extended Release Tablets, 5 mg and 10
(NDA). mg, were also previously listed in the
DEPARTMENT OF HEALTH AND The 1984 amendments include what ‘‘Discontinued Drug Product List’’
HUMAN SERVICES is now section 505(j)(7) of the Federal section of the Orange Book, they are
Food, Drug, and Cosmetic Act (21 U.S.C. now listed in the ‘‘Prescription Drug
Food and Drug Administration 355(j)(7)), which requires FDA to Product List’’ section of the Orange
[Docket Nos. FDA–2018–P–1335 and FDA– publish a list of all approved drugs. Book.
2018–P–1361] FDA publishes this list as part of the Hyman, Phelps & McNamara, P.C.,
‘‘Approved Drug Products With submitted a citizen petition dated
Determination That DITROPAN XL Therapeutic Equivalence Evaluations,’’ March 30, 2018 (Docket No. FDA–2018–
(Oxybutynin Chloride) Extended which is known generally as the P–1335), and Ajanta Pharma Limited
Release Tablets, 15 Milligrams, Were ‘‘Orange Book.’’ Under FDA regulations, submitted a citizen petition dated April
Not Withdrawn From Sale for Reasons drugs are removed from the list if the 2, 2018 (Docket No. FDA–2018–P–
of Safety or Effectiveness Agency withdraws or suspends 1361), under 21 CFR 10.30, requesting
approval of the drug’s NDA or ANDA that the Agency determine whether
AGENCY: Food and Drug Administration,
for reasons of safety or effectiveness or DITROPAN XL (oxybutynin chloride)
HHS.
if FDA determines that the listed drug Extended Release Tablets, 5 mg, 10 mg,
ACTION: Notice. was withdrawn from sale for reasons of and 15 mg, were withdrawn from sale
SUMMARY: The Food and Drug safety or effectiveness (21 CFR 314.162). for reasons of safety or effectiveness.
A person may petition the Agency to As noted, DITROPAN XL (oxybutynin
Administration (FDA or Agency) has
determine, or the Agency may chloride) Extended Release Tablets, 5
determined that DITROPAN XL
determine on its own initiative, whether mg and 10 mg, are no longer listed in
(oxybutynin chloride) Extended Release
a listed drug was withdrawn from sale the ‘‘Discontinued Drug Product List’’
Tablets, 15 milligrams (mg), were not
for reasons of safety or effectiveness. section of the Orange Book, and
withdrawn from sale for reasons of
This determination may be made at any therefore we need not determine
safety or effectiveness. This
time after the drug has been withdrawn whether they were withdrawn from sale
determination will allow FDA to
from sale, but must be made prior to for reasons of safety or effectiveness.
approve abbreviated new drug With regard to DITROPAN XL
approving an ANDA that refers to the
applications (ANDAs) for DITROPAN (oxybutynin chloride) Extended Release
listed drug (§ 314.161 (21 CFR 314.161)).
XL (oxybutynin chloride) Extended Tablets, 15 mg, after considering the
FDA may not approve an ANDA that
Release Tablets, 15 mg, if all other legal citizen petition and reviewing Agency
does not refer to a listed drug.
and regulatory requirements are met. DITROPAN XL (oxybutynin chloride) records, and based on the information
FOR FURTHER INFORMATION CONTACT: Glen Extended Release Tablets, 5 mg, 10 mg, we have at this time, FDA has
amozie on DSK3GDR082PROD with NOTICES1
Cheng, Center for Drug Evaluation and and 15 mg, are the subject of NDA determined under § 314.161 that
Research, Food and Drug 020897, held by Janssen DITROPAN XL (oxybutynin chloride)
Administration, 10903 New Hampshire Pharmaceuticals Inc., and initially Extended Release Tablets, 15 mg, were
Ave., Bldg. 51, Rm. 6210, Silver Spring, approved on December 16, 1998. not withdrawn from sale for reasons of
MD 20993–0002, 301–796–1494. DITROPAN XL is indicated for the safety or effectiveness. The petitioners
SUPPLEMENTARY INFORMATION: In 1984, treatment of overactive bladder with have identified no data or other
Congress enacted the Drug Price symptoms of urge urinary incontinence, information suggesting that this drug
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![Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42513
product was withdrawn for reasons of FDA’s Nutrition Innovation Strategy. Staff, FDA will post your comment, as
safety or effectiveness. We have We are extending the comment period well as any attachments, except for
carefully reviewed our files for records to give interested parties more time to information submitted, marked and
concerning the withdrawal of comment. identified, as confidential, if submitted
DITROPAN XL (oxybutynin chloride) DATES: FDA is extending the comment as detailed in ‘‘Instructions.’’
Extended Release Tablets, 15 mg, from period on the notice and its request for Instructions: All submissions received
sale. We have also independently comment, published in the Federal must include the Docket No. FDA–
evaluated relevant literature and data Register of June 27, 2018 (83 FR 30180). 2018–N–2381 for ‘‘The Food and Drug
for possible postmarketing adverse Submit either electronic or written Administration’s Comprehensive, Multi-
events. We have found no information comments by October 11, 2018. Year Nutrition Innovation Strategy;
that would indicate that this drug ADDRESSES: You may submit comments Public Meeting; Request for Comments.’’
product was withdrawn from sale for as follows. Please note that late, Received comments, those filed in a
reasons of safety or effectiveness. untimely filed comments will not be timely manner (see ADDRESSES), will be
Accordingly, the Agency will considered. Electronic comments must placed in the docket and, except for
continue to list DITROPAN XL be submitted on or before October 11, those submitted as ‘‘Confidential
(oxybutynin chloride) Extended Release 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
Tablets, 15 mg, in the ‘‘Discontinued electronic filing system will accept https://www.regulations.gov or at the
Drug Product List’’ section of the Orange comments until midnight Eastern Time, Dockets Management Staff between 9
Book. The ‘‘Discontinued Drug Product October 11, 2018. Comments received a.m. and 4 p.m., Monday through
List’’ delineates, among other items, by mail/hand delivery/courier (for Friday.
drug products that have been written/paper submissions) will be
discontinued from marketing for reasons • Confidential Submissions—To
considered timely if they are submit a comment with confidential
other than safety or effectiveness. postmarked or the delivery service
ANDAs that refer to DITROPAN XL information that you do not wish to be
acceptance receipt is on or before that made publicly available, submit your
(oxybutynin chloride) Extended Release date.
Tablets, 15 mg, may be approved by the comments only as a written/paper
Agency as long as they meet all other Electronic Submissions submission. You should submit two
legal and regulatory requirements for Submit electronic comments in the copies total. One copy will include the
the approval of ANDAs. If FDA following way: information you claim to be confidential
determines that labeling for this drug • Federal eRulemaking Portal: with a heading or cover note that states
product should be revised to meet https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
current standards, the Agency will instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ We
advise ANDA applicants to submit such Comments submitted electronically, will review this copy, including the
labeling. including attachments, to https:// claimed confidential information, in our
Dated: August 15, 2018. www.regulations.gov will be posted to consideration of comments. The second
the docket unchanged. Because your copy, which will have the claimed
Leslie Kux,
comment will be made public, you are confidential information redacted/
Associate Commissioner for Policy. blacked out, will be available for public
[FR Doc. 2018–18045 Filed 8–21–18; 8:45 am] solely responsible for ensuring that your
comment does not include any viewing and posted on https://
BILLING CODE 4164–01–P
confidential information that you or a www.regulations.gov. Submit both
third party may not wish to be posted, copies to the Dockets Management Staff.
such as medical information, your or If you do not wish your name and
DEPARTMENT OF HEALTH AND contact information to be made publicly
HUMAN SERVICES anyone else’s Social Security number, or
confidential business information, such available, you can provide this
as a manufacturing process. Please note information on the cover sheet and not
Food and Drug Administration
that if you include your name, contact in the body of your comments and you
[Docket No. FDA–2018–N–2381]
information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
The Food and Drug Administration’s as ‘‘confidential’’ will not be disclosed
Comprehensive, Multi-Year Nutrition comments, that information will be
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Innovation Strategy; Extension of the and other applicable disclosure law. For
Comment Period • If you want to submit a comment
with confidential information that you more information about FDA’s posting
AGENCY: Food and Drug Administration, do not wish to be made available to the of comments to public dockets, see 80
HHS. public, submit the comment as a FR 56469, September 18, 2015, or access
written/paper submission and in the the information at: https://www.gpo.gov/
Notice; extension of the
ACTION:
fdsys/pkg/FR-2015-09-18/pdf/2015-
comment period. manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug Docket: For access to the docket to
Administration (FDA or we) is Written/Paper Submissions read background documents or the
extending the comment period for the Submit written/paper submissions as electronic and written/paper comments
notice of a public meeting and request follows: received, go to https://
amozie on DSK3GDR082PROD with NOTICES1
for comments, published in the Federal • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Register of June 27, 2018. The notice written/paper submissions): Dockets docket number, found in brackets in the
announced a public meeting entitled Management Staff (HFA–305), Food and heading of this document, into the
‘‘FDA’s Comprehensive, Multi-Year Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Nutrition Innovation Strategy’’ and Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
invited interested parties to provide • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
information on specific topics related to submitted to the Dockets Management Rockville, MD 20852.
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Document Created: 2018-08-22 00:39:20
Document Modified: 2018-08-22 00:39:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 83 FR 42512 |
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