82 FR 55378 - Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 223 (November 21, 2017)

Page Range		55378-55379
FR Document		2017-25156

The Food and Drug Administration (FDA or Agency) has determined that TRINTELLIX (vortioxetine hydrobromide) oral tablet, equivalent to (EQ) 15 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for vortioxetine hydrobromide oral tablet, 15 mg base, if all other legal and regulatory requirements are met.

Federal Register, Volume 82 Issue 223 (Tuesday, November 21, 2017)

[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Notices]
[Pages 55378-55379]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-P-3989, FDA-2017-P-4195, FDA-2017-P-5114, FDA-
2017-P-5909, FDA-2017-P-5910, and FDA-2017-P-5967]


Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral 
Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons 
of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that TRINTELLIX (vortioxetine hydrobromide) oral tablet, 
equivalent to (EQ) 15 milligram (mg) base, was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for 
vortioxetine hydrobromide oral tablet, 15 mg base, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Meadow W. Platt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-1830.

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.
    TRINTELLIX (vortioxetine hydrobromide) oral tablets, EQ 5 mg base, 
EQ 10 mg base, EQ 15 mg base, and EQ 20 mg base, are the subject of NDA 
204447, held by Takeda Pharmaceuticals, USA, Inc., and initially 
approved on September 30, 2013. TRINTELLIX is indicated for the 
treatment of major depressive disorder.
    TRINTELLIX (vortioxetine hydrobromide) oral tablets, EQ 5 mg base, 
EQ 10 mg base, and EQ 20 mg base, are listed in the ``Prescription Drug 
Product List'' section of the Orange Book, and TRINTELLIX (vortioxetine 
hydrobromide) oral tablet, EQ 15 mg base, is listed in the 
``Discontinued Drug Product List'' section of the Orange Book. Takeda 
Pharmaceuticals, USA, Inc., has never marketed TRINTELLIX (vortioxetine 
hydrobromide) oral tablet, EQ 15 mg base. In previous instances (see, 
e.g., 72 FR 9763 (March 5, 2007), 61 FR 25497 (May 21, 1996)), the 
Agency has determined that, for purposes of Sec. Sec.  314.161 and 
314.162, never marketing an approved drug product is equivalent to 
withdrawing the drug from sale.
    Lachman Consultant Services, Inc.; INC Research, LLC; Locke Lord, 
LLP; Goodwin Procter, LLP; Cipla USA Inc.; and Apotex, Inc., submitted 
citizen petitions dated June 29, 2017; July 12, 2017; August 21, 2017; 
September 25, 2017; September 25, 2017; and September 27, 2017, 
respectively (Docket Nos. FDA-2017-P-3989, FDA-

[[Page 55379]]

2017-P-4195, FDA-2017-P-5114, FDA 2017-P-5909, FDA-2017-P-5910, and 
FDA-2017-P-5967) (collectively, ``citizen petitions''). Under 21 CFR 
10.30, the citizen petitions requested that the Agency determine 
whether TRINTELLIX (vortioxetine hydrobromide) oral tablet, EQ 15 mg 
base, was withdrawn from sale for reasons of safety or effectiveness. 
Lachman Consultant Services, Inc., and INC Research also asked FDA to 
accept ANDAs for all four strengths of TRINTELLIX (vortioxetine 
hydrobromide) tablets: EQ 5 mg base, EQ 10 mg base, EQ 15 mg base, and 
EQ 20 mg base. Because TRINTELLIX (vortioxetine hydrobromide) oral 
tablets, EQ 5 mg base, EQ 10 mg base, and EQ 20 mg base, are not listed 
in the ``Discontinued Drug Product List'' section of the Orange Book, 
these strengths do not require a determination as to whether they were 
withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petitions and reviewing Agency 
records and based on the information we have at this time, FDA has 
determined under Sec.  314.161 that TRINTELLIX (vortioxetine 
hydrobromide) oral tablet, EQ 15 mg base, was not withdrawn for reasons 
of safety or effectiveness. The petitioners have identified no data or 
other information suggesting that TRINTELLIX (vortioxetine 
hydrobromide) oral tablet, EQ 15 mg base, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of TRINTELLIX (vortioxetine 
hydrobromide) oral tablet, EQ 15 mg base, 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 TRINTELLIX 
(vortioxetine hydrobromide) oral tablet, EQ 15 mg base, 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 TRINTELLIX 
(vortioxetine hydrobromide) oral tablet, EQ 15 mg base (as well as 
those that refer to TRINTELLIX (vortioxetine hydrobromide) oral 
tablets, EQ 5 mg base, EQ 10 mg base, and EQ 20 mg base), 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: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-25156 Filed 11-20-17; 8:45 am]
BILLING CODE 4164-01-P

55378 Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices

million. Part B enrollees who are also Dated: October 27, 2017. gain approval of a new drug application
enrolled in Medicaid have their Seema Verma, (NDA).
monthly Part B premiums paid by Administrator, Centers for Medicare & The 1984 amendments include what
Medicaid. The cost to each state Medicaid Services. is now section 505(j)(7) of the Federal
Medicaid program from the 2018 Dated: November 1, 2017. Food, Drug, and Cosmetic Act (21 U.S.C.
premium increase is estimated to be less Eric D. Hargan, 355(j)(7)), which requires FDA to
than the threshold. This notice does not Acting Secretary, Department of Health and
publish a list of all approved drugs.
impose mandates that will have a Human Services. FDA publishes this list as part of the
‘‘Approved Drug Products With
consequential effect of the threshold [FR Doc. 2017–24877 Filed 11–17–17; 4:15 pm]
Therapeutic Equivalence Evaluations,’’
amount or more on state, local, or tribal BILLING CODE 4120–01–P
which is known generally as the
governments or on the private sector. ‘‘Orange Book.’’ Under FDA regulations,
Executive Order 13132 establishes drugs are removed from the list if the
DEPARTMENT OF HEALTH AND
certain requirements that an agency Agency withdraws or suspends
HUMAN SERVICES
must meet when it publishes a proposed approval of the drug’s NDA or ANDA
rule (and subsequent final rule) that Food and Drug Administration for reasons of safety or effectiveness or
imposes substantial direct compliance if FDA determines that the listed drug
costs on state and local governments, [Docket Nos. FDA–2017–P–3989, FDA– was withdrawn from sale for reasons of
preempts state law, or otherwise has 2017–P–4195, FDA–2017–P–5114, FDA– safety or effectiveness (21 CFR 314.162).
2017–P–5909, FDA–2017–P–5910, and FDA– A person may petition the Agency to
Federalism implications. We have
2017–P–5967] determine, or the Agency may
determined that this notice does not
significantly affect the rights, roles, and determine on its own initiative, whether
Determination That TRINTELLIX a listed drug was withdrawn from sale
responsibilities of states. Accordingly, (Vortioxetine Hydrobromide) Oral for reasons of safety or effectiveness.
the requirements of Executive Order Tablet, EQ 15 Milligram Base, Was Not This determination may be made at any
13132 do not apply to this notice. Withdrawn From Sale for Reasons of time after the drug has been withdrawn
In accordance with the provisions of Safety or Effectiveness from sale, but must be made prior to
Executive Order 12866, this notice was AGENCY: Food and Drug Administration, approving an ANDA that refers to the
reviewed by the Office of Management HHS. listed drug (§ 314.161 (21 CFR 314.161)).
and Budget. FDA may not approve an ANDA that
ACTION: Notice.
does not refer to a listed drug.
V. Waiver of Proposed Notice TRINTELLIX (vortioxetine
SUMMARY: The Food and Drug
Administration (FDA or Agency) has hydrobromide) oral tablets, EQ 5 mg
The Medicare statute requires the
determined that TRINTELLIX base, EQ 10 mg base, EQ 15 mg base,
publication of the monthly actuarial
(vortioxetine hydrobromide) oral tablet, and EQ 20 mg base, are the subject of
rates and the Part B premium amounts NDA 204447, held by Takeda
in September. We ordinarily use general equivalent to (EQ) 15 milligram (mg)
base, was not withdrawn from sale for Pharmaceuticals, USA, Inc., and
notices, rather than notice and comment initially approved on September 30,
rulemaking procedures, to make such reasons of safety or effectiveness. This
determination will allow FDA to 2013. TRINTELLIX is indicated for the
announcements. In doing so, we note treatment of major depressive disorder.
that, under the Administrative approve abbreviated new drug
TRINTELLIX (vortioxetine
applications (ANDAs) for vortioxetine
Procedure Act, interpretive rules, hydrobromide) oral tablets, EQ 5 mg
hydrobromide oral tablet, 15 mg base, if
general statements of policy, and rules base, EQ 10 mg base, and EQ 20 mg
all other legal and regulatory
of agency organization, procedure, or base, are listed in the ‘‘Prescription Drug
requirements are met.
practice are excepted from the Product List’’ section of the Orange
FOR FURTHER INFORMATION CONTACT: Book, and TRINTELLIX (vortioxetine
requirements of notice and comment
Meadow W. Platt, Center for Drug hydrobromide) oral tablet, EQ 15 mg
rulemaking.
Evaluation and Research, Food and base, is listed in the ‘‘Discontinued Drug
We considered publishing a proposed Drug Administration, 10903 New Product List’’ section of the Orange
notice to provide a period for public Hampshire Ave., Bldg. 51, Rm. 6228, Book. Takeda Pharmaceuticals, USA,
comment. However, we may waive that Silver Spring, MD 20993–0002, 301– Inc., has never marketed TRINTELLIX
procedure if we find, for good cause, 796–1830. (vortioxetine hydrobromide) oral tablet,
that prior notice and comment are SUPPLEMENTARY INFORMATION: In 1984, EQ 15 mg base. In previous instances
impracticable, unnecessary, or contrary Congress enacted the Drug Price (see, e.g., 72 FR 9763 (March 5, 2007),
to the public interest. The statute Competition and Patent Term 61 FR 25497 (May 21, 1996)), the
establishes the time period for which Restoration Act of 1984 (Pub. L. 98–417) Agency has determined that, for
the premium rates will apply, and (the 1984 amendments), which purposes of §§ 314.161 and 314.162,
delaying publication of the Part B authorized the approval of duplicate never marketing an approved drug
premium rate such that it would not be versions of drug products under an product is equivalent to withdrawing
published before that time would be ANDA procedure. ANDA applicants the drug from sale.
asabaliauskas on DSKBBXCHB2PROD with NOTICES

contrary to the public interest. must, with certain exceptions, show that Lachman Consultant Services, Inc.;
Moreover, we find that notice and the drug for which they are seeking INC Research, LLC; Locke Lord, LLP;
comment are unnecessary because the approval contains the same active Goodwin Procter, LLP; Cipla USA Inc.;
formulas used to calculate the Part B ingredient in the same strength and and Apotex, Inc., submitted citizen
premiums are statutorily directed. dosage form as the ‘‘listed drug,’’ which petitions dated June 29, 2017; July 12,
Therefore, we find good cause to waive is a version of the drug that was 2017; August 21, 2017; September 25,
publication of a proposed notice and previously approved. ANDA applicants 2017; September 25, 2017; and
solicitation of public comments. do not have to repeat the extensive September 27, 2017, respectively
clinical testing otherwise necessary to (Docket Nos. FDA–2017–P–3989, FDA–

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Document Created: 2017-11-21 00:43:15
Document Modified: 2017-11-21 00:43:15

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		Meadow W. Platt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301- 796-1830.
FR Citation		82 FR 55378

82 FR 55378 - Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 223 (November 21, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration