82 FR 43384 - Determination That TIMOPTIC (Timolol Maleate Ophthalmic Solution), 0.25 Percent and 0.5 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 178 (September 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 178 (September 15, 2017)
| Page Range | 43384-43385 | |
| FR Document | 2017-19610 |
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)] [Notices] [Pages 43384-43385] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19610] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-1108] Determination That TIMOPTIC (Timolol Maleate Ophthalmic Solution), 0.25 Percent and 0.5 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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or Agency) has determined that TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. 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, a drug is 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. TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, is the subject of NDA 018086, held by Aton Pharma, Inc. and initially approved on August 17, 1978. TIMOPTIC is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, is currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Orbicular Pharmaceutical Technologies, Pvt. Ltd., submitted a citizen petition dated February 22, 2017 (Docket No. FDA-2017-P-1108), under 21 CFR 10.30, requesting that the Agency determine whether TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, was withdrawn from sale 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 TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was [[Page 43385]] withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, 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 TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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: September 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19610 Filed 9-14-17; 8:45 am] BILLING CODE 4164-01-P
![43384 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
blunt or sharp, and of varying lengths. of information in 21 CFR part 807, a version of the drug that was
This document discusses when subpart E, regarding premarket previously approved. ANDA applicants
microneedling products are devices as notification submissions, have been do not have to repeat the extensive
defined under section 201(h) of the approved under OMB control number clinical testing otherwise necessary to
FD&C Act (21 U.S.C. 321(h)). This draft 0910–0120, and the collections of gain approval of a new drug application
guidance also provides clarity on the information in 21 CFR part 801, (NDA).
regulatory pathway to market for regarding device labeling, have been The 1984 amendments include what
microneedling devices, resulting in approved under OMB control number is now section 505(j)(7) of the Federal
more transparency and predictability to 0910–0485. Food, Drug, and Cosmetic Act (21 U.S.C.
firms and stakeholders, which may 355(j)(7)), which requires FDA to
Dated: September 7, 2017.
translate into more efficient device publish a list of all approved drugs.
Anna K. Abram,
development and patient access to such FDA publishes this list as part of the
devices. The scope of this guidance Deputy Commissioner for Policy, Planning, ‘‘Approved Drug Products with
Legislation, and Analysis. Therapeutic Equivalence Evaluations,’’
document does not include
[FR Doc. 2017–19614 Filed 9–14–17; 8:45 am] which is known generally as the Orange
microneedling combination products,
acupuncture needles, hypodermic BILLING CODE 4164–01–P Book. Under FDA regulations, a drug is
needles or other needles for injection, removed from the list if the Agency
tattoo machine needles, and needle withdraws or suspends approval of the
probes that emit any type of energy (e.g., DEPARTMENT OF HEALTH AND drug’s NDA or ANDA for reasons of
radiofrequency needles) or deliver any HUMAN SERVICES safety or effectiveness or if FDA
type of energy to a patient (e.g., LASER, determines that the listed drug was
Food and Drug Administration
ultrasound). withdrawn from sale for reasons of
[Docket No. FDA–2017–P–1108] safety or effectiveness (21 CFR 314.162).
II. Significance of Guidance A person may petition the Agency to
This draft guidance is being issued Determination That TIMOPTIC (Timolol determine, or the Agency may
consistent with FDA’s good guidance Maleate Ophthalmic Solution), 0.25 determine on its own initiative, whether
practices regulation (21 CFR 10.115). Percent and 0.5 Percent, Was Not a listed drug was withdrawn from sale
The draft guidance, when finalized, will Withdrawn From Sale for Reasons of for reasons of safety or effectiveness.
represent the current thinking of FDA Safety or Effectiveness This determination may be made at any
on this topic. It does not establish any time after the drug has been withdrawn
AGENCY: Food and Drug Administration,
rights for any person and is not binding from sale, but must be made prior to
HHS.
on FDA or the public. You can use an approving an ANDA that refers to the
alternative approach if it satisfies the ACTION: Notice. listed drug (§ 314.161 (21 CFR 314.161)).
requirements of the applicable statutes SUMMARY: The Food and Drug FDA may not approve an ANDA that
and regulations. This guidance is not Administration (FDA or Agency) has does not refer to a listed drug.
subject to Executive Order 12866. determined that TIMOPTIC (timolol TIMOPTIC (timolol maleate
ophthalmic solution), 0.25 percent and
III. Electronic Access maleate ophthalmic solution), 0.25
0.5 percent, is the subject of NDA
percent and 0.5 percent, was not
Persons interested in obtaining a copy 018086, held by Aton Pharma, Inc. and
withdrawn from sale for reasons of
of the draft guidance may do so by initially approved on August 17, 1978.
safety or effectiveness. This
downloading an electronic copy from TIMOPTIC is indicated for the treatment
determination means that FDA will not
the internet. A search capability for all of elevated intraocular pressure in
begin procedures to withdraw approval
Center for Devices and Radiological patients with ocular hypertension or
of abbreviated new drug applications
Health guidance documents is available open-angle glaucoma.
(ANDAs) that refer to this drug product, TIMOPTIC (timolol maleate
at http://www.fda.gov/MedicalDevices/
and it will allow FDA to continue to ophthalmic solution), 0.25 percent and
DeviceRegulationandGuidance/
approve ANDAs that refer to the 0.5 percent, is currently listed in the
GuidanceDocuments/default.htm. This
product as long as they meet relevant ‘‘Discontinued Drug Product List’’
guidance document is also available at
legal and regulatory requirements. section of the Orange Book. Orbicular
https://www.regulations.gov. Persons
unable to download an electronic copy FOR FURTHER INFORMATION CONTACT: Pharmaceutical Technologies, Pvt. Ltd.,
of ‘‘Regulatory Considerations for Robin Fastenau, Center for Drug submitted a citizen petition dated
Microneedling Devices—Draft Guidance Evaluation and Research, Food and February 22, 2017 (Docket No. FDA–
for Industry and Food and Drug Drug Administration, 10903 New 2017–P–1108), under 21 CFR 10.30,
Administration Staff’’ may send an Hampshire Ave., Bldg. 51, Rm. 6236, requesting that the Agency determine
email request to CDRH-Guidance@ Silver Spring, MD 20993–0002, 240– whether TIMOPTIC (timolol maleate
fda.hhs.gov to receive an electronic 402–4510. ophthalmic solution), 0.25 percent and
copy of the document. Please use the SUPPLEMENTARY INFORMATION: In 1984, 0.5 percent, was withdrawn from sale
document number 1500036 to identify Congress enacted the Drug Price for reasons of safety or effectiveness.
the guidance you are requesting. Competition and Patent Term After considering the citizen petition
Restoration Act of 1984 (Pub. L. 98–417) and reviewing Agency records and
IV. Paperwork Reduction Act of 1995 (the 1984 amendments), which based on the information we have at this
This draft guidance refers to authorized the approval of duplicate time, FDA has determined under
mstockstill on DSK30JT082PROD with NOTICES
previously approved collections of versions of drug products under an § 314.161 that TIMOPTIC (timolol
information found in FDA regulations. ANDA procedure. ANDA applicants maleate ophthalmic solution), 0.25
These collections of information are must, with certain exceptions, show that percent and 0.5 percent, was not
subject to review by the Office of the drug for which they are seeking withdrawn for reasons of safety or
Management and Budget (OMB) under approval contains the same active effectiveness. The petitioner has
the Paperwork Reduction Act of 1995 ingredient in the same strength and identified no data or other information
(44 U.S.C. 3501–3520). The collections dosage form as the listed drug, which is suggesting that this drug product was
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![Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices 43385
withdrawn for reasons of safety or effectiveness summaries of approved • Confidential Submissions—To
effectiveness. We have carefully PMAs through the internet and the submit a comment with confidential
reviewed our files for records Agency’s Dockets Management Staff. information that you do not wish to be
concerning the withdrawal of ADDRESSES: You may submit comments made publicly available, submit your
TIMOPTIC (timolol maleate ophthalmic as follows: comments only as a written/paper
solution), 0.25 percent and 0.5 percent, submission. You should submit two
from sale. We have also independently Electronic Submissions copies total. One copy will include the
evaluated relevant literature and data Submit electronic comments in the information you claim to be confidential
for possible postmarketing adverse following way: with a heading or cover note that states
events. We have found no information • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
that would indicate that this drug https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
product was withdrawn from sale for instructions for submitting comments. Agency will review this copy, including
reasons of safety or effectiveness. Comments submitted electronically, the claimed confidential information, in
Accordingly, the Agency will including attachments, to https:// its consideration of comments. The
continue to list TIMOPTIC (timolol www.regulations.gov will be posted to second copy, which will have the
maleate ophthalmic solution), 0.25 the docket unchanged. Because your claimed confidential information
percent and 0.5 percent, in the comment will be made public, you are redacted/blacked out, will be available
‘‘Discontinued Drug Product List’’ solely responsible for ensuring that your for public viewing and posted on
section of the Orange Book. The comment does not include any https://www.regulations.gov. Submit
‘‘Discontinued Drug Product List’’ confidential information that you or a both copies to the Dockets Management
delineates, among other items, drug Staff Office. If you do not wish your
third party may not wish to be posted,
products that have been discontinued name and contact information to be
such as medical information, your or
from marketing for reasons other than made publicly available, you can
anyone else’s Social Security number, or
safety or effectiveness. FDA will not provide this information on the cover
confidential business information, such
begin procedures to withdraw approval sheet and not in the body of your
as a manufacturing process. Please note
of approved ANDAs that refer to this comments and you must identify this
that if you include your name, contact
drug product. Additional ANDAs for information as ‘‘confidential.’’ Any
information, or other information that
this drug product may also be approved information marked as ‘‘confidential’’
identifies you in the body of your
by the Agency as long as they meet all will not be disclosed except in
comments, that information will be
other legal and regulatory requirements accordance with 21 CFR 10.20 and other
posted on https://www.regulations.gov.
for the approval of ANDAs. If FDA
• If you want to submit a comment applicable disclosure law. For more
determines that labeling for this drug information about FDA’s posting of
with confidential information that you
product should be revised to meet comments to public dockets, see 80 FR
do not wish to be made available to the
current standards, the Agency will 56469, September 18, 2015, or access
public, submit the comment as a
advise ANDA applicants to submit such the information at: https://www.gpo.gov/
written/paper submission and in the
labeling. fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper
Dated: September 11, 2017. Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Anna K. Abram, Docket: For access to the docket to
Deputy Commissioner for Policy, Planning,
Written/Paper Submissions read background documents or the
Legislation, and Analysis. Submit written/paper submissions as electronic and written/paper comments
[FR Doc. 2017–19610 Filed 9–14–17; 8:45 am] follows: received, go to https://
BILLING CODE 4164–01–P • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
written/paper submissions): Dockets docket number, found in brackets in the
Management Staff (HFA–305), Food and heading of this document, into the
DEPARTMENT OF HEALTH AND Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
HUMAN SERVICES Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
• For written/paper comments Staff office, 5630 Fishers Lane, Rm.
Food and Drug Administration submitted to the Dockets Management 1061, Rockville, MD 20852.
[Docket Nos. FDA–2016–M–4529 and FDA– Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
2017–M–3899] well as any attachments, except for Jonathan McKnight, Center for Biologics
information submitted, marked and Evaluation and Research, Food and
Medical Devices Regulated by the identified, as confidential, if submitted Drug Administration, 10903 New
Center for Biologics Evaluation and as detailed in ‘‘Instructions.’’ Hampshire Ave., Bldg. 71, Rm. 7301,
Research; Availability of Safety and Instructions: All submissions received Silver Spring, MD 20993–0002, 240–
Effectiveness Summaries for must include the Docket Nos. FDA– 402–7911.
Premarket Approval Applications 2016–M–4529 and FDA–2017–M–3899 SUPPLEMENTARY INFORMATION:
AGENCY: Food and Drug Administration, for ‘‘Medical Devices Regulated by the
Center for Biologics Evaluation and I. Background
HHS.
ACTION: Notice. Research; Availability of Safety and In accordance with sections 515(d)(4)
Effectiveness Summaries for Premarket and (e)(2) of the Federal Food, Drug, and
SUMMARY: The Food and Drug Approval Applications.’’ Received Cosmetic Act (the FD&C Act) (21 U.S.C.
mstockstill on DSK30JT082PROD with NOTICES
Administration (FDA or Agency) is comments will be placed in the docket 360e(d)(4) and (e)(2)), notification of an
publishing a list of premarket approval and, except for those submitted as order approving, denying, or
applications (PMAs) that have been ‘‘Confidential Submissions,’’ publicly withdrawing approval of a PMA will
approved by the Center for Biologics viewable at https://www.regulations.gov continue to include a notice of
Evaluation and Research (CBER). This or at the Dockets Management Staff opportunity to request review of the
list is intended to inform the public of Office between 9 a.m. and 4 p.m., order under section 515(g) of the FD&C
the availability of safety and Monday through Friday. Act. The 30-day period for requesting
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Document Created: 2017-09-15 00:18:56
Document Modified: 2017-09-15 00:18:56
| 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 | 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. | |
| FR Citation | 82 FR 43384 |
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