[Federal Register Volume 82, Number 223 (Tuesday, November 21, 2017)]
[Notices]
[Pages 55378-55379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons 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equivalent to (EQ) 15 milligram (mg) base, was not withdrawn from sale 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