82 FR 38910 - Determination That CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 157 (August 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 157 (August 16, 2017)
| Page Range | 38910-38911 | |
| FR Document | 2017-17302 |
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)] [Notices] [Pages 38910-38911] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17302] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-0495] Determination That CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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(FDA or Agency) has determined that CORDARONE (amiodarone hydrochloride) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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: Jennifer Forde, Center for Drug [[Page 38911]] Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301- 348-3035. 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. CORDARONE (amiodarone hydrochloride) tablets, 200 mg, are the subject of NDA 018972, held by Wyeth Pharmaceuticals, Inc. (a subsidiary of Pfizer, Inc.), and initially approved on December 24, 1985. CORDARONE is indicated for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated: (1) Recurrent ventricular fibrillation and (2) recurrent hemodynamically unstable ventricular tachycardia. In correspondence dated February 7, 2017, Pfizer, Inc. notified FDA that CORDARONE (amiodarone hydrochloride) tablets, 200 mg, were being discontinued, and FDA moved the drug product to the ``Discontinued Drug Product List'' section of the Orange Book. Lachman Consultant Services, Inc. submitted a citizen petition dated January 25, 2017 (Docket No. FDA-2017-P-0495), under 21 CFR 10.30, requesting that the Agency determine whether CORDARONE (amiodarone hydrochloride) tablets, 200 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 CORDARONE (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CORDARONE (amiodarone hydrochloride) tablets, 200 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CORDARONE (amiodarone hydrochloride) tablets, 200 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 CORDARONE (amiodarone hydrochloride) tablets, 200 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. 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: August 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-17302 Filed 8-15-17; 8:45 am] BILLING CODE 4164-01-P
![38910 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices
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information on the cover sheet and not Dated: August 11, 2017.
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in the body of your comments and you Anna K. Abram,
If FDA is unable to post the background
must identify this information as material on its Web site prior to the Deputy Commissioner for Policy, Planning,
‘‘confidential.’’ Any information marked Legislation, and Analysis.
meeting, the background material will
as ‘‘confidential’’ will not be disclosed be made publicly available at the [FR Doc. 2017–17303 Filed 8–15–17; 8:45 am]
except in accordance with 21 CFR 10.20 location of the advisory committee BILLING CODE 4164–01–P
and other applicable disclosure law. For meeting, and the background material
more information about FDA’s posting will be posted on FDA’s Web site after
of comments to public dockets, see 80 DEPARTMENT OF HEALTH AND
the meeting. Background material is
FR 56469, September 18, 2015, or access HUMAN SERVICES
available at https://www.fda.gov/
the information at: https://www.gpo.gov/ AdvisoryCommittees/Calendar/ Food and Drug Administration
fdsys/pkg/FR-2015-09-18/pdf/2015- default.htm. Scroll down to the
23389.pdf. appropriate advisory committee meeting [Docket No. FDA–2017–P–0495]
Docket: For access to the docket to link.
read background documents or the Procedure: Interested persons may Determination That CORDARONE
electronic and written/paper comments present data, information, or views, (Amiodarone Hydrochloride) Tablets,
received, go to https:// 200 milligrams, Were Not Withdrawn
orally or in writing, on issues pending
www.regulations.gov and insert the From Sale for Reasons of Safety or
before the committees. All electronic
docket number, found in brackets in the Effectiveness
and written submissions submitted to
heading of this document, into the the docket (see ADDRESSES) on or before AGENCY: Food and Drug Administration,
‘‘Search’’ box and follow the prompts August 30, 2017, will be provided to the HHS.
and/or go to the Dockets Management committees. Oral presentations from the ACTION: Notice.
Staff, 5630 Fishers Lane, Rm. 1061, public will be scheduled between
Rockville, MD 20852. approximately 10:15 a.m. and 11:15 a.m. SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: Those individuals interested in making Administration (FDA or Agency) has
Stephanie L. Begansky, Center for Drug formal oral presentations should notify determined that CORDARONE
Evaluation and Research, Food and the contact person and submit a brief (amiodarone hydrochloride) tablets, 200
Drug Administration, 10903 New statement of the general nature of the milligrams (mg), were not withdrawn
Hampshire Ave., Bldg. 31, Rm. 2417, evidence or arguments they wish to from sale for reasons of safety or
Silver Spring, MD 20993–0002, 301– present, the names and addresses of effectiveness. This determination means
796–9001, Fax: 301–847–8533, email: proposed participants, and an that FDA will not begin procedures to
withdraw approval of abbreviated new
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AADPAC@fda.hhs.gov, or FDA indication of the approximate time
Advisory Committee Information Line, requested to make their presentation on drug applications (ANDAs) that refer to
1–800–741–8138 (301–443–0572 in the or before August 22, 2017. Time allotted this drug product, and it will allow FDA
Washington, DC area). A notice in the for each presentation may be limited. If to continue to approve ANDAs that refer
Federal Register about last minute the number of registrants requesting to to the product as long as they meet
modifications that impact a previously speak is greater than can be reasonably relevant legal and regulatory
announced advisory committee meeting accommodated during the scheduled requirements.
cannot always be published quickly open public hearing session, FDA may FOR FURTHER INFORMATION CONTACT:
enough to provide timely notice. conduct a lottery to determine the Jennifer Forde, Center for Drug
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![Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 38911
Evaluation and Research, Food and (2) recurrent hemodynamically unstable Dated: August 11, 2017.
Drug Administration, 10903 New ventricular tachycardia. Anna K. Abram,
Hampshire Ave., Bldg. 51, Rm. 6213, In correspondence dated February 7, Deputy Commissioner for Policy, Planning,
Silver Spring, MD 20993–0002, 301– 2017, Pfizer, Inc. notified FDA that Legislation, and Analysis.
348–3035. CORDARONE (amiodarone [FR Doc. 2017–17302 Filed 8–15–17; 8:45 am]
SUPPLEMENTARY INFORMATION: In 1984, hydrochloride) tablets, 200 mg, were BILLING CODE 4164–01–P
Congress enacted the Drug Price being discontinued, and FDA moved the
Competition and Patent Term drug product to the ‘‘Discontinued Drug
Restoration Act of 1984 (Pub. L. 98–417) Product List’’ section of the Orange DEPARTMENT OF HEALTH AND
(the 1984 amendments), which Book. HUMAN SERVICES
authorized the approval of duplicate Lachman Consultant Services, Inc. Food and Drug Administration
versions of drug products under an submitted a citizen petition dated
ANDA procedure. ANDA applicants [Docket No. FDA–2017–N–3966]
January 25, 2017 (Docket No. FDA–
must, with certain exceptions, show that 2017–P–0495), under 21 CFR 10.30,
the drug for which they are seeking Upsher-Smith Laboratories, Inc.;
requesting that the Agency determine Withdrawal of Approval of an
approval contains the same active whether CORDARONE (amiodarone
ingredient in the same strength and Abbreviated New Drug Application for
hydrochloride) tablets, 200 mg, were ZALEPLON
dosage form as the ‘‘listed drug,’’ which
withdrawn from sale for reasons of
is a version of the drug that was AGENCY: Food and Drug Administration,
safety or effectiveness.
previously approved. ANDA applicants HHS.
do not have to repeat the extensive After considering the citizen petition
and reviewing Agency records and ACTION: Notice.
clinical testing otherwise necessary to
gain approval of a new drug application based on the information we have at this SUMMARY: The Food and Drug
(NDA). time, FDA has determined under Administration (FDA or the Agency) is
The 1984 amendments include what § 314.161 that CORDARONE withdrawing approval of an abbreviated
is now section 505(j)(7) of the Federal (amiodarone hydrochloride) tablets, 200 new drug application (ANDA) for
Food, Drug, and Cosmetic Act (21 U.S.C. mg, were not withdrawn for reasons of ZALEPLON Capsules, 5 milligrams (mg)
355(j)(7)), which requires FDA to safety or effectiveness. The petitioner and 10 mg, held by Upsher-Smith
publish a list of all approved drugs. has identified no data or other Laboratories, Inc. (Upsher-Smith), 6701
FDA publishes this list as part of the information suggesting that Evenstad Dr., Maple Grove, MN 55369.
‘‘Approved Drug Products with CORDARONE (amiodarone Upsher-Smith has voluntarily requested
Therapeutic Equivalence Evaluations,’’ hydrochloride) tablets, 200 mg, were that approval of this application be
which is known generally as the withdrawn for reasons of safety or withdrawn, and has waived its
‘‘Orange Book.’’ Under FDA regulations, effectiveness. We have carefully opportunity for a hearing.
drugs are removed from the list if the reviewed our files for records DATES: Effective August 16, 2017.
Agency withdraws or suspends concerning the withdrawal of FOR FURTHER INFORMATION CONTACT:
approval of the drug’s NDA or ANDA CORDARONE (amiodarone Stefanie Kraus, Center for Drug
for reasons of safety or effectiveness or hydrochloride) tablets, 200 mg, from Evaluation and Research, Food and
if FDA determines that the listed drug sale. We have also independently Drug Administration, 10903 New
was withdrawn from sale for reasons of evaluated relevant literature and data Hampshire Ave., Bldg. 51, Rm. 6215,
safety or effectiveness (21 CFR 314.162). for possible postmarketing adverse Silver Spring, MD 20993–0002, 301–
A person may petition the Agency to events. We have reviewed the available 796–9585.
determine, or the Agency may evidence and determined that this drug
SUPPLEMENTARY INFORMATION: On June 6,
determine on its own initiative, whether product was not withdrawn from sale
2008, FDA approved ANDA 078706 for
a listed drug was withdrawn from sale for reasons of safety or effectiveness.
ZALEPLON Capsules, 5 mg and 10 mg,
for reasons of safety or effectiveness. Accordingly, the Agency will submitted by Upsher-Smith. According
This determination may be made at any continue to list CORDARONE to annual reports Upsher-Smith filed
time after the drug has been withdrawn (amiodarone hydrochloride) tablets, 200 with the Agency, Upsher-Smith stopped
from sale, but must be made prior to mg, in the ‘‘Discontinued Drug Product distributing these products by April 6,
approving an ANDA that refers to the List’’ section of the Orange Book. The 2010. In a letter dated August 9, 2011,
listed drug (§ 314.161 (21 CFR 314.161)). ‘‘Discontinued Drug Product List’’ FDA informed Upsher-Smith that it had
FDA may not approve an ANDA that delineates, among other items, drug concerns about the validity of
does not refer to a listed drug. products that have been discontinued bioequivalence data submitted with
CORDARONE (amiodarone from marketing for reasons other than ANDA 078706 from studies conducted
hydrochloride) tablets, 200 mg, are the safety or effectiveness. FDA will not by a certain contract research
subject of NDA 018972, held by Wyeth begin procedures to withdraw approval organization, establishing
Pharmaceuticals, Inc. (a subsidiary of of approved ANDAs that refer to this bioequivalence of Upsher-Smith’s
Pfizer, Inc.), and initially approved on drug product. Additional ANDAs for product to the reference listed drug,
this drug product may also be approved
asabaliauskas on DSKBBXCHB2PROD with NOTICES
December 24, 1985. CORDARONE is SONATA (ZALEPLON) Capsules, 5 mg
indicated for the treatment of the by the Agency as long as they meet all and 10 mg. In that letter, FDA directed
following documented, life-threatening other legal and regulatory requirements Upsher-Smith to supplement its ANDA
recurrent ventricular arrhythmias when for the approval of ANDAs. If FDA with either: (1) New bioequivalence
these have not responded to determines that labeling for this drug studies or (2) re-assays of the samples
documented adequate doses of other product should be revised to meet from the original bioequivalence
available antiarrhythmics or when current standards, the Agency will studies. Upsher-Smith did not respond
alternative agents could not be tolerated: advise ANDA applicants to submit such to this letter. FDA then sent another
(1) Recurrent ventricular fibrillation and labeling. letter to Upsher-Smith on August 19,
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Document Created: 2017-08-16 10:27:02
Document Modified: 2017-08-16 10:27:02
| 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 | Jennifer Forde, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301- 348-3035. | |
| FR Citation | 82 FR 38910 |
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