Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 55378-55379 [2017-25156]

Download as PDF 55378 Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices million. Part B enrollees who are also enrolled in Medicaid have their monthly Part B premiums paid by Medicaid. The cost to each state Medicaid program from the 2018 premium increase is estimated to be less than the threshold. This notice does not impose mandates that will have a consequential effect of the threshold amount or more on state, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule (and subsequent final rule) that imposes substantial direct compliance costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have determined that this notice does not significantly affect the rights, roles, and responsibilities of states. Accordingly, the requirements of Executive Order 13132 do not apply to this notice. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. asabaliauskas on DSKBBXCHB2PROD with NOTICES V. Waiver of Proposed Notice 18:56 Nov 20, 2017 Jkt 244001 [FR Doc. 2017–24877 Filed 11–17–17; 4:15 pm] BILLING CODE 4120–01–P 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FDA– 2017–P–5967] Determination That TRINTELLIX (Vortioxetine Hydrobromide) Oral Tablet, EQ 15 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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. 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determined that TRINTELLIX (vortioxetine hydrobromide) oral tablet, equivalent to (EQ) 15 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness.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 SUMMARY: The Medicare statute requires the publication of the monthly actuarial rates and the Part B premium amounts in September. We ordinarily use general notices, rather than notice and comment rulemaking procedures, to make such announcements. In doing so, we note that, under the Administrative Procedure Act, interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice are excepted from the requirements of notice and comment rulemaking. We considered publishing a proposed notice to provide a period for public comment. However, we may waive that procedure if we find, for good cause, that prior notice and comment are impracticable, unnecessary, or contrary to the public interest. The statute establishes the time period for which the premium rates will apply, and delaying publication of the Part B premium rate such that it would not be published before that time would be contrary to the public interest. Moreover, we find that notice and comment are unnecessary because the formulas used to calculate the Part B premiums are statutorily directed. Therefore, we find good cause to waive publication of a proposed notice and solicitation of public comments. VerDate Sep<11>2014 Dated: October 27, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: November 1, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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. 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 §§ 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– E:\FR\FM\21NON1.SGM 21NON1 asabaliauskas on DSKBBXCHB2PROD with NOTICES Federal Register / Vol. 82, No. 223 / Tuesday, November 21, 2017 / Notices 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 § 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 VerDate Sep<11>2014 18:56 Nov 20, 2017 Jkt 244001 55379 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. at the end of January 22, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Dated: November 3, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). [FR Doc. 2017–25156 Filed 11–20–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6162] Agency Information Collection Activities; Proposed Collection; Comment Request Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on eligibility criteria and the process to be followed by establishments when notifying FDA of a manufacturer’s intent to have an accredited third party conduct a quality systems regulation inspection of their establishment instead of FDA, under the Accredited Persons (AP) Inspection Program. DATES: Submit either electronic or written comments on the collection of information by January 22, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–N–6162 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the E:\FR\FM\21NON1.SGM 21NON1

Agencies

[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.

-----------------------------------------------------------------------

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