82 FR 42103 - Determination That RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 82, Issue 171 (September 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 171 (September 6, 2017)
| Page Range | 42103-42104 | |
| FR Document | 2017-18817 |
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)] [Notices] [Pages 42103-42104] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18817] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-2496] Determination That RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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has determined that RITALIN LA (methylphenidate hydrochloride) extended- release capsules, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 methylphenidate hydrochloride extended-release capsules, 60 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 240- 402-3543. 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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, are the subject of NDA 021284, held by Novartis Pharmaceuticals Corp. (Novartis) and initially approved on October 27, 2014. RITALIN LA is indicated for the [[Page 42104]] treatment of Attention Deficit Hyperactivity Disorder (ADHD). In a letter dated March 23, 2016, Novartis notified FDA that RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were being discontinued, and FDA moved the drug product to the ``Discontinued Drug Product List'' section of the Orange Book. Abhai, LLC, submitted a citizen petition dated April 19, 2017 (Docket No. FDA-2017-P-2496), under 21 CFR 10.30, requesting that the Agency determine whether RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were 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 RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 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 RITALIN LA (methylphenidate hydrochloride) extended-release capsules, 60 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 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18817 Filed 9-5-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42103
provides recommendations for the control number 0910–0332; the allow FDA to approve abbreviated new
content of premarket submissions and collections of information in 21 CFR drug applications (ANDAs) for
labeling for such devices. part 601 have been approved under methylphenidate hydrochloride
In the Federal Register of January 26, OMB control number 0910–0338; the extended-release capsules, 60 mg, if all
2016 (81 FR 4303), FDA announced the collections of information in 21 CFR other legal and regulatory requirements
availability of the draft of this guidance parts 801 and 809 have been approved are met.
and interested persons were invited to under OMB control number 0910–0485; FOR FURTHER INFORMATION CONTACT:
comment by March 28, 2016. The and the collections of information in 21 Christopher Koepke, Center for Drug
comment period was extended on CFR parts 610 and 660 have been Evaluation and Research, Food and
February 23, 2016 (81 FR 8966), to April approved under OMB control number Drug Administration, 10903 New
28, 2016. FDA has considered all of the 0910–0338. Hampshire Ave., Bldg. 51, Rm. 6224,
public comments received in finalizing Silver Spring, MD 20993–0002, 240–
this guidance. IV. Electronic Access
402–3543.
FDA recognizes and anticipates that Persons interested in obtaining a copy
of the guidance may do so by SUPPLEMENTARY INFORMATION: In 1984,
the Agency and industry may need up
to 60 days to perform activities to downloading an electronic copy from Congress enacted the Drug Price
operationalize the policies within the the Internet. A search capability for all Competition and Patent Term
guidance. If new information regarding Center for Devices and Radiological Restoration Act of 1984 (Pub. L. 98–417)
device interoperability as outlined in Health guidance documents is available (the 1984 amendments), which
this guidance is not included in a at https://www.fda.gov/MedicalDevices/ authorized the approval of duplicate
premarket submission received by FDA DeviceRegulationandGuidance/ versions of drug products under an
before or up to 60 days after the GuidanceDocuments/default.htm. ANDA procedure. ANDA applicants
publication of this guidance, CDRH staff Guidance documents are also available must, with certain exceptions, show that
does not generally intend to request at https://www.fda.gov/BiologicsBlood the drug for which they are seeking
such information during the review of Vaccines/GuidanceCompliance approval contains the same active
the submission. CDRH does, however, RegulatoryInformation/default.htm or ingredient in the same strength and
intend to review any such information https://www.regulations.gov. Persons dosage form as the ‘‘listed drug,’’ which
if submitted. unable to download an electronic copy is a version of the drug that was
of ‘‘Design Considerations and previously approved. ANDA applicants
II. Significance of Guidance do not have to repeat the extensive
Premarket Submission
This guidance is being issued Recommendations for Interoperable clinical testing otherwise necessary to
consistent with FDA’s good guidance Medical Devices’’ may send an email gain approval of a new drug application
practices regulation (21 CFR 10.115). request to CDRH-Guidance@fda.hhs.gov (NDA).
The guidance represents the current to receive an electronic copy of the The 1984 amendments include what
thinking of FDA on ‘‘Design document. Please use the document is now section 505(j)(7) of the Federal
Considerations and Premarket number 1500015 to identify the Food, Drug, and Cosmetic Act (21 U.S.C.
Submission Recommendations for guidance you are requesting. 355(j)(7)), which requires FDA to
Interoperable Medical Devices.’’ It does publish a list of all approved drugs.
Dated: August 30, 2017.
not establish any rights for any person FDA publishes this list as part of the
Leslie Kux,
and is not binding on FDA or the public. ‘‘Approved Drug Products With
Associate Commissioner for Policy. Therapeutic Equivalence Evaluations,’’
You can use an alternative approach if
[FR Doc. 2017–18815 Filed 9–5–17; 8:45 am] which is known generally as the
it satisfies the requirements of the
applicable statutes and regulations. This BILLING CODE 4164–01–P ‘‘Orange Book.’’ Under FDA regulations,
guidance is not subject to Executive drugs are removed from the list if the
Order 12866. Agency withdraws or suspends
DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA
III. Paperwork Reduction Act of 1995 HUMAN SERVICES for reasons of safety or effectiveness or
This guidance refers to previously if FDA determines that the listed drug
Food and Drug Administration
approved collections of information was withdrawn from sale for reasons of
found in FDA regulations. These [Docket No. FDA–2017–P–2496] safety or effectiveness (21 CFR 314.162).
collections of information are subject to A person may petition the Agency to
review by the Office of Management and Determination That RITALIN LA determine, or the Agency may
Budget (OMB) under the Paperwork (Methylphenidate Hydrochloride) determine on its own initiative, whether
Reduction Act of 1995 (44 U.S.C. 3501– Extended-Release Capsules, 60 a listed drug was withdrawn from sale
3520). The collections of information in Milligrams, Were Not Withdrawn From for reasons of safety or effectiveness.
21 CFR part 820 have been approved Sale for Reasons of Safety or This determination may be made at any
under OMB control number 0910–0073; Effectiveness time after the drug has been withdrawn
the collections of information in 21 CFR AGENCY: Food and Drug Administration, from sale, but must be made prior to
part 812 have been approved under HHS. approving an ANDA that refers to the
OMB control number 0910–0078; the ACTION: Notice. listed drug (21 CFR 314.161). FDA may
asabaliauskas on DSKBBXCHB2PROD with NOTICES
collections of information in 21 CFR not approve an ANDA that does not
part 807, subpart E, have been approved SUMMARY: The Food and Drug refer to a listed drug.
under OMB control number 0910–0120; Administration (FDA or Agency) has RITALIN LA (methylphenidate
the collections of information in 21 CFR determined that RITALIN LA hydrochloride) extended-release
part 814, subparts A through E, have (methylphenidate hydrochloride) capsules, 60 mg, are the subject of NDA
been approved under OMB control extended-release capsules, 60 021284, held by Novartis
number 0910–0231; the collections of milligrams (mg), were not withdrawn Pharmaceuticals Corp. (Novartis) and
information in 21 CFR part 814, subpart from sale for reasons of safety or initially approved on October 27, 2014.
H have been approved under OMB effectiveness. This determination will RITALIN LA is indicated for the
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![42104 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
treatment of Attention Deficit Dated: August 28, 2017. p.m., National Cancer Institute—Shady
Hyperactivity Disorder (ADHD). Anna K. Abram, Grove, 9609 Medical Center Drive,
In a letter dated March 23, 2016, Deputy Commissioner for Policy, Planning, Conference Room TE406 and TE408,
Novartis notified FDA that RITALIN LA Legislation, and Analysis. Rockville, MD, 20850 (Virtual Meeting)
(methylphenidate hydrochloride) [FR Doc. 2017–18817 Filed 9–5–17; 8:45 am] which was published in the Federal
extended-release capsules, 60 mg, were BILLING CODE 4164–01–P Register on August 14, 2017, 82 FR
being discontinued, and FDA moved the 37885.
drug product to the ‘‘Discontinued Drug The meeting notice is amended to
Product List’’ section of the Orange DEPARTMENT OF HEALTH AND change the times of the open and closed
Book. HUMAN SERVICES sessions. The open session will end at
2:15 p.m. The closed session will begin
Abhai, LLC, submitted a citizen National Institutes of Health at 2:30 p.m. and end at 3:30 p.m. The
petition dated April 19, 2017 (Docket meeting is partially closed to the public.
No. FDA–2017–P–2496), under 21 CFR National Institute on Aging; Notice of
10.30, requesting that the Agency Closed Meeting Dated: August 30, 2017.
determine whether RITALIN LA Melanie J. Pantoja,
Pursuant to section 10(d) of the Program Analyst Office of Federal Advisory
(methylphenidate hydrochloride)
Federal Advisory Committee Act, as Committee Policy.
extended-release capsules, 60 mg, were
amended, notice is hereby given of the [FR Doc. 2017–18804 Filed 9–5–17; 8:45 am]
withdrawn from sale for reasons of
following meeting.
safety or effectiveness. The meeting will be closed to the
BILLING CODE 4140–01–P
After considering the citizen petition public in accordance with the
and reviewing Agency records, and provisions set forth in sections DEPARTMENT OF HEALTH AND
based on the information we have at this 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HUMAN SERVICES
time, FDA has determined under as amended. The grant applications and
§ 314.161 that RITALIN LA the discussions could disclose National Institutes of Health
(methylphenidate hydrochloride) confidential trade secrets or commercial
extended-release capsules, 60 mg, were property such as patentable material, National Institute of Diabetes and
not withdrawn for reasons of safety or and personal information concerning Digestive and Kidney Diseases; Notice
effectiveness. The petitioner has individuals associated with the grant of Closed Meetings
identified no data or other information applications, the disclosure of which Pursuant to section 10(d) of the
suggesting that RITALIN LA would constitute a clearly unwarranted Federal Advisory Committee Act, as
(methylphenidate hydrochloride) invasion of personal privacy. amended, notice is hereby given of the
extended-release capsules, 60 mg, were Name of Committee: National Institute on following meetings.
withdrawn for reasons of safety or Aging Initial Review Group; Clinical Aging The meetings will be closed to the
effectiveness. We have carefully Review Committee. public in accordance with the
reviewed our files for records Date: October 5–6, 2017. provisions set forth in sections
concerning the withdrawal of RITALIN Time: 3:30 p.m. to 1:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
LA (methylphenidate hydrochloride) Agenda: To review and evaluate grant
applications. as amended. The grant applications and
extended-release capsules, 60 mg, from the discussions could disclose
sale. We have also independently Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814. confidential trade secrets or commercial
evaluated relevant literature and data Contact Person: Alicja L. Markowska, property such as patentable material,
for possible postmarketing adverse Ph.D., DSC, National Institute on Aging, and personal information concerning
events. We have reviewed the available National Institutes of Health, Gateway individuals associated with the grant
evidence and determined that this drug Building 2C212, 7201 Wisconsin Avenue, applications, the disclosure of which
product was not withdrawn from sale Bethesda, MD 20892, 301–496–9666, would constitute a clearly unwarranted
for reasons of safety or effectiveness. markowsa@nia.nih.gov.
invasion of personal privacy.
Accordingly, the Agency will (Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research, Name of Committee: National Institute of
continue to list RITALIN LA National Institutes of Health, HHS) Diabetes and Digestive and Kidney Diseases
(methylphenidate hydrochloride) Special Emphasis Panel; PAR–15–067:
extended-release capsules, 60 mg, in the Dated: August 30, 2017. NIDDK Multi-Center Clinical Study
‘‘Discontinued Drug Product List’’ Melanie J. Pantoja, Cooperative Agreement (U01): CKD and Bone
section of the Orange Book. The Program Analyst, Office of Federal Advisory Mineral Disorders in Children.
‘‘Discontinued Drug Product List’’ Committee Policy. Date: October 2, 2017.
Time: 11:00 a.m. to 2:00 p.m.
delineates, among other items, drug [FR Doc. 2017–18805 Filed 9–5–17; 8:45 am]
Agenda: To review and evaluate
products that have been discontinued BILLING CODE 4140–01–P cooperative agreement applications.
from marketing for reasons other than Place: National Institutes of Health, Two
safety or effectiveness. ANDAs that refer Democracy Plaza, 6707 Democracy
to RITALIN LA (methylphenidate DEPARTMENT OF HEALTH AND Boulevard, Bethesda, MD 20892 (Telephone
hydrochloride) extended-release HUMAN SERVICES Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
capsules, 60 mg, may be approved by
the Agency as long as they meet all National Institutes of Health Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
other legal and regulatory requirements
National Cancer Institute Amended Room 7349, 6707 Democracy Boulevard,
for the approval of ANDAs. If FDA Bethesda, MD 20892–5452, (301) 594–8894,
Notice of Meeting
determines that labeling for this drug begumn@niddk.nih.gov.
product should be revised to meet Notice is hereby given of a change in Name of Committee: National Institute of
current standards, the Agency will the meeting of the National Cancer Diabetes and Digestive and Kidney Diseases
advise ANDA applicants to submit such Advisory Board, September 12, 2017, Special Emphasis Panel, PAR–16–126: High
labeling. 1:00 p.m. to September 12, 2017, 4:00 Impact, Interdisciplinary Science in NIDDK
VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1](https://thefederalregister.org/doc/82_FR_42274/page/2.svg)
Document Created: 2017-09-06 00:56:24
Document Modified: 2017-09-06 00:56:24
| 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 | Christopher Koepke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 240- 402-3543. | |
| FR Citation | 82 FR 42103 |
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