Determination That CORDARONE (Amiodarone Hydrochloride) Tablets, 200 milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 38910-38911 [2017-17302]

Download as PDF asabaliauskas on DSKBBXCHB2PROD with NOTICES 38910 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. 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VerDate Sep<11>2014 18:33 Aug 15, 2017 Jkt 241001 Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committees will discuss supplemental new drug application (sNDA) 021306, for BUTRANS (buprenorphine) transdermal system submitted by Purdue Pharma L.P., evaluating BUTRANS in pediatric patients ages 7 through 16 years for management of pain severe enough to require daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the findings of the clinical study of BUTRANS conducted in pediatric patients, and whether they support additional labeling. 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Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 11:15 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 23, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Stephanie L. Begansky at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–17303 Filed 8–15–17; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: E:\FR\FM\16AUN1.SGM 16AUN1 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301– 348–3035. 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 (§ 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 asabaliauskas on DSKBBXCHB2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:33 Aug 15, 2017 Jkt 241001 (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 § 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. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 38911 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–3966] Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for ZALEPLON Capsules, 5 milligrams (mg) and 10 mg, held by Upsher-Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing. DATES: Effective August 16, 2017. FOR FURTHER INFORMATION CONTACT: Stefanie Kraus, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993–0002, 301– 796–9585. SUPPLEMENTARY INFORMATION: On June 6, 2008, FDA approved ANDA 078706 for ZALEPLON Capsules, 5 mg and 10 mg, submitted by Upsher-Smith. According to annual reports Upsher-Smith filed with the Agency, Upsher-Smith stopped distributing these products by April 6, 2010. In a letter dated August 9, 2011, FDA informed Upsher-Smith that it had concerns about the validity of bioequivalence data submitted with ANDA 078706 from studies conducted by a certain contract research organization, establishing bioequivalence of Upsher-Smith’s product to the reference listed drug, SONATA (ZALEPLON) Capsules, 5 mg and 10 mg. In that letter, FDA directed Upsher-Smith to supplement its ANDA with either: (1) New bioequivalence studies or (2) re-assays of the samples from the original bioequivalence studies. Upsher-Smith did not respond to this letter. FDA then sent another letter to Upsher-Smith on August 19, SUMMARY: E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Pages 38910-38911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17302]


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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

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