82 FR 38911 - Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 157 (August 16, 2017)

Page Range		38911-38912
FR Document		2017-17301

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 Upsher-Smith has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.

Federal Register, Volume 82 Issue 157 (Wednesday, August 16, 2017)

[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Pages 38911-38912]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17301]


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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.

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SUMMARY: 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application be withdrawn, and has waived its opportunity for a hearing.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,

[[Page 38912]]

2016, requesting that Upsher-Smith provide the requested bioequivalence 
data within 30 calendar days or voluntarily seek withdrawal of ANDA 
078706 under section 314.150(d) (21 CFR 314.150(d)).
    In a letter dated September 15, 2016, Upsher-Smith informed FDA 
that it did not intend to submit the requested bioequivalence data and 
requested that the Agency withdraw approval of ANDA 078706 for ZALEPLON 
Capsules under section 314.150(d). In that letter, Upsher-Smith also 
waived any opportunity for a hearing otherwise provided under section 
314.150(a).
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and 314.150(d), approval of 
ANDA 078706, and all amendments and supplements thereto, is withdrawn 
(see DATES). Distribution of this product in interstate commerce 
without an approved application is illegal and subject to regulatory 
action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 
355(a) and 331(d)).

    Dated: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17301 Filed 8-15-17; 8:45 am]
 BILLING CODE 4164-01-P

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.
Dates		Effective August 16, 2017.
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.
FR Citation		82 FR 38911

82 FR 38911 - Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 157 (August 16, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration