82 FR 49840 - Determination That CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 207 (October 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49840-49841 | |
| FR Document | 2017-23438 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49840-49841] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23438] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-2660] Determination That CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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determined that CARDENE SR (nicardipine HCl) extended-release capsules, 30 milligrams (mg), 45 mg, and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 nicardipine HCl extended-release capsules, 30 mg, 45 mg, and 60 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301- 796-6650. 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 [[Page 49841]] 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. CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 60 mg, are the subject of NDA 020005, initially approved on February 21, 1992. CARDENE SR is indicated for the treatment of hypertension. In a letter dated September 15, 2014, EKR Therapeutics, Inc., requested withdrawal of NDA 020005 for CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 60 mg. In the Federal Register of October 4, 2016 (81 FR 68427), FDA announced that it was withdrawing approval of NDA 020005, effective November 3, 2016. Jubilant Generics submitted a citizen petition dated April 27, 2017 (Docket No. FDA-2017-P-2660), under 21 CFR 10.30, requesting that the Agency determine whether CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 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 CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 60 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CARDENE SR (nicardipine HCl) extended- release capsules, 30 mg, 45 mg, and 60 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 60 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 CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 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 CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45 mg, or 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: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23438 Filed 10-26-17; 8:45 am] BILLING CODE 4164-01-P
![49840 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
collect patient experience data to inform as well as the examples provided. FDA DEPARTMENT OF HEALTH AND
regulatory decision making may use. is also interested in seeking information HUMAN SERVICES
In addition, FDA committed to meet and comments on additional examples
certain performance goals under PDUFA where the approaches proposed in the Food and Drug Administration
VI. These goal commitments were discussion document have been [Docket No. FDA–2017–P–2660]
developed in consultation with patient successfully applied that could be
and consumer advocates, health care included in guidance. After this public Determination That CARDENE SR
professionals, and other public workshop, FDA will take into (Nicardipine HCl) Extended-Release
stakeholders, as part of negotiations Capsules, 30 Milligrams, 45 Milligrams,
consideration the stakeholder input
with regulated industry. Section J.1 of and 60 Milligrams, Were Not
from the workshop and the public
the commitment letter, ‘‘Enhancing the Withdrawn From Sale for Reasons of
Incorporation of the Patient’s Voice in docket, and publish a draft guidance by
the end of the third quarter of fiscal year Safety or Effectiveness
Drug Development and Decision-
Making,’’ (https://www.fda.gov/ 2018. AGENCY: Food and Drug Administration,
downloads/ForIndustry/UserFees/ Registration: Interested parties are HHS.
PrescriptionDrugUserFee/ encouraged to register early. To register ACTION: Notice.
UCM511438.pdf) outlines work, electronically, please visit: https://
including the development of a series of pfdd.eventbrite.com. Persons without SUMMARY: The Food and Drug
guidance documents and associated access to the internet can call 240–402– Administration (FDA or Agency) has
public workshops to facilitate the 6525 to register. If you are unable to determined that CARDENE SR
advancement and use of systematic attend the meeting in person, you can (nicardipine HCl) extended-release
approaches to collect and utilize robust register to view a live webcast of the capsules, 30 milligrams (mg), 45 mg,
and meaningful patient and caregiver meeting. You will be asked to indicate and 60 mg, were not withdrawn from
input that can more consistently inform sale for reasons of safety or
in your registration if you plan to attend
drug development, and, as appropriate, effectiveness. This determination will
in person or via the webcast. Seating
regulatory decision making. allow FDA to approve abbreviated new
Prior to the issuance of each guidance, will be limited, so early registration is
drug applications (ANDAs) for
as part of the development, FDA will recommended. Registration is free and
nicardipine HCl extended-release
conduct a public workshop to gather will be on a first-come, first-served
capsules, 30 mg, 45 mg, and 60 mg, if
input from the wider community of basis. However, FDA may limit the all other legal and regulatory
patients, patient advocates, academic number of participants from each requirements are met.
researchers, expert practitioners, drug organization based on space limitations.
FOR FURTHER INFORMATION CONTACT:
developers, and other stakeholders. Registrants will receive confirmation
Daniel Gottlieb, Center for Drug
once they have been accepted. Onsite
II. Purpose and Scope of Meeting Evaluation and Research, Food and
registration on the day of the meeting Drug Administration, 10903 New
FDA is announcing a public will be based on space availability.
workshop to convene a discussion on Hampshire Ave., Bldg. 51, Rm. 6208,
topics related to approaches to If you need special accommodations Silver Spring, MD 20993–0002, 301–
collecting comprehensive and because of a disability, please contact 796–6650.
representative patient and caregiver Meghana Chalasani (see FOR FURTHER SUPPLEMENTARY INFORMATION: In 1984,
input on burden of disease and current INFORMATION CONTACT) at least 7 days Congress enacted the Drug Price
therapy. The purpose of this public before the meeting. Competition and Patent Term
workshop is to obtain feedback from Request for Oral Presentations: There Restoration Act of 1984 (Pub. L. 98–417)
stakeholders on considerations for: (1) will be time allotted during the (the 1984 amendments), which
Standardized nomenclature and workshop for open public comment. authorized the approval of duplicate
terminologies for patient-focused drug Sign-up for this session will be on a versions of drug products under an
development, (2) methods to collect first-come, first-serve basis on the day of ANDA procedure. ANDA applicants
meaningful patient input throughout the the workshop. Individuals and must, with certain exceptions, show that
drug development process, and (3) organizations with common interests are the drug for which they are seeking
methodological considerations for data approval contains the same active
urged to consolidate or coordinate, and
collection, reporting, management, and ingredient in the same strength and
request time for a joint presentation. No
analysis of patient input. FDA is seeking dosage form as the listed drug, which is
information and comments from a broad commercial or promotional material a version of the drug that was
range of stakeholders, including will be permitted to be presented or previously approved. ANDA applicants
patients, patient advocates, academic distributed at the public workshop. do not have to repeat the extensive
and medical researchers, expert Transcripts: As soon as a transcript is clinical testing otherwise necessary to
practitioners, drug developers, and available, FDA will post it at https:// gain approval of a new drug application
other interested persons. FDA will www.fda.gov/Drugs/NewsEvents/ (NDA).
publish a discussion document ucm574725.htm. The 1984 amendments include what
outlining the topic areas that will be is now section 505(j)(7) of the Federal
Dated: October 23, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
addressed in the draft guidance. This Food, Drug, and Cosmetic Act (21 U.S.C.
document will be published Anna K. Abram, 355(j)(7)), which requires FDA to
approximately 1 month before the Deputy Commissioner for Policy, Planning, publish a list of all approved drugs.
workshop date on the Web site at: Legislation, and Analysis. FDA publishes this list as part of the
https://www.fda.gov/Drugs/NewsEvents/ [FR Doc. 2017–23437 Filed 10–26–17; 8:45 am] ‘‘Approved Drug Products with
ucm574725.htm. FDA is interested in BILLING CODE 4164–01–P Therapeutic Equivalence Evaluations,’’
seeking information and comments on which is known generally as the Orange
the approaches and considerations Book. Under FDA regulations, drugs are
proposed in the discussion document, removed from the list if the Agency
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![Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49841
withdraws or suspends approval of the Accordingly, the Agency will in brackets in the heading of this
drug’s NDA or ANDA for reasons of continue to list CARDENE SR document.
safety or effectiveness or if FDA (nicardipine HCl) extended-release FOR FURTHER INFORMATION CONTACT:
determines that the listed drug was capsules, 30 mg, 45 mg, and 60 mg, in Amber Sanford, Office of Operations,
withdrawn from sale for reasons of the ‘‘Discontinued Drug Product List’’ Food and Drug Administration, Three
safety or effectiveness (21 CFR 314.162). section of the Orange Book. The White Flint North, 10A–12M, 11601
A person may petition the Agency to ‘‘Discontinued Drug Product List’’ Landsdown St., North Bethesda, MD
determine, or the Agency may delineates, among other items, drug 20852, 301–796–8867, PRAStaff@
determine on its own initiative, whether products that have been discontinued
a listed drug was withdrawn from sale fda.hhs.gov.
from marketing for reasons other than
for reasons of safety or effectiveness. safety or effectiveness. ANDAs that refer SUPPLEMENTARY INFORMATION: In
This determination may be made at any to CARDENE SR (nicardipine HCl) compliance with 44 U.S.C. 3507, FDA
time after the drug has been withdrawn extended-release capsules, 30 mg, 45 has submitted the following proposed
from sale, but must be made prior to mg, or 60 mg, may be approved by the collection of information to OMB for
approving an ANDA that refers to the Agency as long as they meet all other review and clearance.
listed drug (§ 314.161 (21 CFR 314.161)). legal and regulatory requirements for Generic Clearance for the Collection of
FDA may not approve an ANDA that the approval of ANDAs. If FDA Qualitative Feedback on Agency
does not refer to a listed drug. determines that labeling for this drug
CARDENE SR (nicardipine HCl) Service Delivery
product should be revised to meet
extended-release capsules, 30 mg, 45 current standards, the Agency will OMB Control Number 0910–0697—
mg, and 60 mg, are the subject of NDA advise ANDA applicants to submit such Extension
020005, initially approved on February labeling.
21, 1992. CARDENE SR is indicated for The information collection activity
the treatment of hypertension. Dated: October 24, 2017. will garner qualitative customer and
In a letter dated September 15, 2014, Anna K. Abram, stakeholder feedback in an efficient,
EKR Therapeutics, Inc., requested Deputy Commissioner for Policy, Planning, timely manner in accordance with the
withdrawal of NDA 020005 for Legislation, and Analysis. Administration’s commitment to
CARDENE SR (nicardipine HCl) [FR Doc. 2017–23438 Filed 10–26–17; 8:45 am] improving service delivery. By
extended-release capsules, 30 mg, 45 BILLING CODE 4164–01–P
qualitative feedback we mean
mg, and 60 mg. In the Federal Register information that provides useful
of October 4, 2016 (81 FR 68427), FDA insights on perceptions and opinions,
announced that it was withdrawing DEPARTMENT OF HEALTH AND but are not statistical surveys that yield
approval of NDA 020005, effective HUMAN SERVICES quantitative results that can be
November 3, 2016. generalized to the population of study.
Jubilant Generics submitted a citizen Food and Drug Administration This voluntary feedback will provide
petition dated April 27, 2017 (Docket insights into customer or stakeholder
[Docket No. FDA–2014–N–0487]
No. FDA–2017–P–2660), under 21 CFR perceptions, experiences and
10.30, requesting that the Agency Agency Information Collection expectations, provide an early warning
determine whether CARDENE SR Activities; Submission for Office of of issues with service, or focus attention
(nicardipine HCl) extended-release Management and Budget Review; on areas where communication,
capsules, 30 mg, 45 mg, and 60 mg, Comment Request; Generic Clearance training, or changes in operations might
were withdrawn from sale for reasons of for the Collection of Qualitative improve delivery of products or
safety or effectiveness. Feedback on Agency Service Delivery services. These collections will allow
After considering the citizen petition for ongoing, collaborative, and
and reviewing Agency records and AGENCY: Food and Drug Administration, actionable communications between the
based on the information we have at this HHS. Agency and its customers and
time, FDA has determined under ACTION: Notice. stakeholders. It will also allow feedback
§ 314.161 that CARDENE SR to contribute directly to the
(nicardipine HCl) extended-release SUMMARY: The Food and Drug improvement of program management.
capsules, 30 mg, 45 mg, and 60 mg, Administration (FDA) is announcing Feedback collected under this generic
were not withdrawn for reasons of that a proposed collection of clearance will provide useful
safety or effectiveness. The petitioner information has been submitted to the information, but it will not yield data
has identified no data or other Office of Management and Budget that can be generalized to the overall
information suggesting that CARDENE (OMB) for review and clearance under population. This type of generic
SR (nicardipine HCl) extended-release the Paperwork Reduction Act of 1995. clearance for qualitative information
capsules, 30 mg, 45 mg, and 60 mg, DATES: Fax written comments on the will not be used for quantitative
were withdrawn for reasons of safety or collection of information by November information collections that are
effectiveness. We have carefully 27, 2017. designed to yield reliably actionable
reviewed our files for records ADDRESSES: To ensure that comments on results, such as monitoring trends over
concerning the withdrawal of CARDENE the information collection are received, time or documenting program
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SR (nicardipine HCl) extended-release OMB recommends that written performance. Such data uses require
capsules, 30 mg, 45 mg, and 60 mg from comments be faxed to the Office of more rigorous designs that address the
sale. We have also independently Information and Regulatory Affairs, following: The target population to
evaluated relevant literature and data OMB, Attn: FDA Desk Officer, Fax: 202– which generalizations will be made, the
for possible postmarketing adverse 395–7285, or emailed to oira_ sampling frame, the sample design
events. We have found no information submission@omb.eop.gov. All (including stratification and clustering),
that would indicate that this drug comments should be identified with the the precision requirements or power
product was withdrawn from sale for OMB control number 0910–0697. Also calculations that justify the proposed
reasons of safety or effectiveness. include the FDA docket number found sample size, the expected response rate,
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Document Created: 2017-10-27 02:05:59
Document Modified: 2017-10-27 02:05:59
| 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 | Daniel Gottlieb, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301- 796-6650. | |
| FR Citation | 82 FR 49840 |
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