81_FR_50858 81 FR 50710 - Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

81 FR 50710 - Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 148 (August 2, 2016)

Page Range50710-50711
FR Document2016-18139

The Food and Drug Administration (FDA or Agency) has determined that SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal and regulatory requirements are met.

Federal Register, Volume 81 Issue 148 (Tuesday, August 2, 2016) 
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50710-50711]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-0974]


Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams, 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were 
not withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240-
402-3543.

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

[[Page 50711]]

safety or effectiveness (Sec.  314.162 (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). FDA may not approve an ANDA that does not refer 
to a listed drug.
    SAMSCA (tolvaptan) tablets, 60 mg, are the subject of NDA 22-275, 
held by Otsuka America Pharmaceutical, and initially approved on May 
19, 2009. SAMSCA is indicated for the treatment of clinically 
significant hypervolemic and euvolemic hyponatremia (serum sodium <125 
milliequivalents/liter or less marked hyponatremia that is symptomatic 
and has resisted correction with fluid restriction), including patients 
with heart failure and syndrome of inappropriate antidiuretic hormone 
(SIADH).
    Otsuka America Pharmaceutical has never marketed SAMSCA (tolvaptan) 
tablets, 60 mg. 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.
    Gordon Johnston Regulatory Consultants, LLC, submitted a citizen 
petition dated March 15, 2016 (Docket No. FDA-2016-P-0974), under 21 
CFR 10.30, requesting that the Agency determine whether SAMSCA 
(tolvaptan) tablets, 60 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 SAMSCA (tolvaptan) tablets, 60 mg, were not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that SAMSCA 
(tolvaptan) tablets, 60 mg, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of SAMSCA (tolvaptan) tablets, 60 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 SAMSCA (tolvaptan) 
tablets, 60 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. ANDAs that 
refer to SAMSCA (tolvaptan) tablets, 60 mg, 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: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18139 Filed 8-1-16; 8:45 am]
 BILLING CODE 4164-01-P

50710 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices rule entitled, ‘‘Requirements for Blood provisions in § 630.10 if the donation is DEPARTMENT OF HEALTH AND and Blood Components Intended for intended solely for autologous use. HUMAN SERVICES Transfusion or for Further Sections 630.15(a) and 630.20(a) Manufacturing Use,’’ 80 FR 29842 Food and Drug Administration describe conditions for which a (donor eligibility rule)) that became responsible physician must examine [Docket No. FDA–2016–P–0974] effective on May 23, 2016. A small proportion of collections of and determine and document that the autologous donor’s health permits a Determination That SAMSCA blood and blood components are (Tolvaptan) Tablets, 60 Milligrams, intended for autologous transfusion. In collection procedure. Autologous donors are under the care of the Were Not Withdrawn From Sale for those instances, the autologous donor Reasons of Safety or Effectiveness presents with a physician’s prescription physician who prescribes the for the collection of the donor’s blood autologous donation. In light of the AGENCY: Food and Drug Administration, for the donor’s own upcoming medical medical oversight provided by the HHS. (e.g., surgical) procedure. If the donor autologous donor’s physician, FDA ACTION: Notice. ultimately does not need the blood, believes blood establishments can blood establishments may, in some appropriately protect autologous SUMMARY: The Food and Drug instances, use these donations for donors’ health by following standard Administration (FDA or Agency) has allogeneic (i.e. intended for transfusion operating procedures that are approved determined that SAMSCA (tolvaptan) to a recipient other than the donor) by the responsible physician of the tablets, 60 milligrams (mg), were not transfusions. This is referred to as blood establishment and that define withdrawn from sale for reasons of ‘‘cross-over.’’ criteria for when the autologous safety or effectiveness. This Blood establishments have requested donation may proceed and the determination will allow FDA to clarification on certain requirements of conditions under which the responsible approve abbreviated new drug the donor eligibility rule and the applications (ANDAs) for tolvaptan physician must be consulted. applicability of certain sections of the tablets, 60 mg, if all other legal and donor eligibility rule to the collection of The guidance explains the conditions regulatory requirements are met. blood and blood components intended under which FDA does not intend to FOR FURTHER INFORMATION CONTACT: for autologous use. To address these take regulatory action for a blood Christopher Koepke, Center for Drug questions, FDA has developed this establishment’s failure to comply with Evaluation and Research, Food and guidance to clarify the Agency’s policy the donor eligibility determination Drug Administration, 10903 New with respect to the requirements for requirements in collecting blood and Hampshire Ave., Bldg. 51, Rm. 6214, autologous donors of blood and blood blood components intended solely for Silver Spring, MD 20993–0002, 240– components intended solely for autologous use. 402–3543. autologous use, (i.e., not subject to The guidance represents the current cross-over). Specifically, the guidance SUPPLEMENTARY INFORMATION: In 1984, thinking of the FDA on this topic. It Congress enacted the Drug Price describes FDA’s policy with respect to does not establish any rights for any Competition and Patent Term the following: The requirements in 21 person and is not binding on FDA or the Restoration Act of 1984 (Pub. L. 98–417) CFR 630.10 related to screening autologous donors for relevant public. You can use an alternative (the 1984 amendments), which transfusion-transmitted infections; the approach if it satisfies the requirements authorized the approval of duplicate requirement in 21 CFR 630.15(a)(1)(ii) of the applicable statutes and versions of drug products under an that the responsible physician examine regulations. ANDA procedure. ANDA applicants the autologous donor to permit more must, with certain exceptions, show that II. Paperwork Reduction Act of 1995 frequent collections; and, the the drug for which they are seeking requirement in 21 CFR 630.20(a) that This guidance refers to previously approval contains the same active the responsible physician determine approved collections of information ingredient in the same strength and and document that the autologous found in FDA regulations. These dosage form as the ‘‘listed drug,’’ which donor’s health permits the collection of collections of information are subject to is a version of the drug that was blood and blood components intended review by the Office of Management and previously approved. ANDA applicants for autologous use. Budget (OMB) under the Paperwork do not have to repeat the extensive Autologous donors have long been Reduction Act of 1995 (44 U.S.C. 3501– clinical testing otherwise necessary to permitted to donate blood for their own gain approval of a new drug application 3520). The collections of information in use even if they do not meet certain (NDA). part 630 have been approved under donor eligibility criteria that apply to The 1984 amendments include what OMB control number 0910–0795. allogeneic donors because autologous is now section 505(j)(7) of the Federal donors are not exposed to new III. Electronic Access Food, Drug, and Cosmetic Act (21 U.S.C. transfusion-transmitted infections in 355(j)(7)), which requires FDA to receiving their own blood. For example, Persons with access to the Internet publish a list of all approved drugs. FDA does not require testing of may obtain the guidance at either http:// FDA publishes this list as part of the autologous donations for Relevant www.fda.gov/BiologicsBloodVaccines/ ‘‘Approved Drug Products With Transfusion-Transmitted Infection GuidanceComplianceRegulatory Therapeutic Equivalence Evaluations,’’ (RTTI) unless the donations are used for Information/Guidances/default.htm or which is known generally as the mstockstill on DSK3G9T082PROD with NOTICES allogeneic transfusion or shipped to http://www.regulations.gov. ‘‘Orange Book.’’ Under FDA regulations, another establishment (21 CFR Dated: July 27, 2016. drugs are removed from the list if the 610.40(d)). Consistent with this Agency withdraws or suspends Leslie Kux, approach to testing autologous approval of the drug’s NDA or ANDA donations, FDA does not believe it is Associate Commissioner for Policy. for reasons of safety or effectiveness or necessary to assess autologous donors [FR Doc. 2016–18183 Filed 8–1–16; 8:45 am] if FDA determines that the listed drug for risks for RTTI as required in certain BILLING CODE 4164–01–P was withdrawn from sale for reasons of VerDate Sep<11>2014 18:35 Aug 01, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM 02AUN1

Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices 50711 safety or effectiveness (§ 314.162 (21 Accordingly, the Agency will guidance before it begins work on the CFR 314.162)). continue to list SAMSCA (tolvaptan) final version of the guidance, submit A person may petition the Agency to tablets, 60 mg, in the ‘‘Discontinued either electronic or written comments determine, or the Agency may Drug Product List’’ section of the Orange on the draft guidance by October 3, determine on its own initiative, whether Book. The ‘‘Discontinued Drug Product 2016. a listed drug was withdrawn from sale List’’ delineates, among other items, ADDRESSES: You may submit comments for reasons of safety or effectiveness. drug products that have been as follows: This determination may be made at any discontinued from marketing for reasons time after the drug has been withdrawn other than safety or effectiveness. Electronic Submissions from sale, but must be made prior to ANDAs that refer to SAMSCA Submit electronic comments in the approving an ANDA that refers to the (tolvaptan) tablets, 60 mg, may be following way: listed drug (§ 314.161). FDA may not approved by the Agency as long as they • Federal eRulemaking Portal: http:// approve an ANDA that does not refer to meet all other legal and regulatory www.regulations.gov. Follow the a listed drug. requirements for the approval of instructions for submitting comments. SAMSCA (tolvaptan) tablets, 60 mg, ANDAs. If FDA determines that labeling Comments submitted electronically, are the subject of NDA 22–275, held by for this drug product should be revised including attachments, to http:// Otsuka America Pharmaceutical, and to meet current standards, the Agency www.regulations.gov will be posted to initially approved on May 19, 2009. will advise ANDA applicants to submit the docket unchanged. Because your SAMSCA is indicated for the treatment such labeling. comment will be made public, you are of clinically significant hypervolemic solely responsible for ensuring that your and euvolemic hyponatremia (serum Dated: July 27, 2016. comment does not include any sodium <125 milliequivalents/liter or Leslie Kux, confidential information that you or a less marked hyponatremia that is Associate Commissioner for Policy. third party may not wish to be posted, symptomatic and has resisted correction [FR Doc. 2016–18139 Filed 8–1–16; 8:45 am] such as medical information, your or with fluid restriction), including BILLING CODE 4164–01–P anyone else’s Social Security number, or patients with heart failure and confidential business information, such syndrome of inappropriate antidiuretic as a manufacturing process. Please note hormone (SIADH). DEPARTMENT OF HEALTH AND that if you include your name, contact Otsuka America Pharmaceutical has HUMAN SERVICES information, or other information that never marketed SAMSCA (tolvaptan) identifies you in the body of your tablets, 60 mg. In previous instances Office of the Secretary comments, that information will be (see, e.g., 72 FR 9763 (March 5, 2007), posted on http://www.regulations.gov. 61 FR 25497 (May 21, 1996)), the Food and Drug Administration • If you want to submit a comment Agency has determined that, for [Docket No. FDA–2016–D–1605] with confidential information that you purposes of §§ 314.161 and 314.162, do not wish to be made available to the never marketing an approved drug Institutional Review Board Written public, submit the comment as a product is equivalent to withdrawing Procedures: Guidance for Institutions written/paper submission and in the the drug from sale. and Institutional Review Boards; Draft manner detailed (see ‘‘Written/Paper Gordon Johnston Regulatory Guidance; Availability Submissions’’ and ‘‘Instructions’’). Consultants, LLC, submitted a citizen petition dated March 15, 2016 (Docket AGENCY: The Office for Human Research Written/Paper Submissions No. FDA–2016–P–0974), under 21 CFR Protections, Office of the Assistant Submit written/paper submissions as 10.30, requesting that the Agency Secretary for Health, Office of the follows: determine whether SAMSCA (tolvaptan) Secretary, HHS, and the Food and Drug • Mail/Hand delivery/Courier (for tablets, 60 mg, were withdrawn from Administration, HHS. written/paper submissions): Division of sale for reasons of safety or ACTION: Notice of availability. Dockets Management (HFA–305), Food effectiveness. and Drug Administration, 5630 Fishers After considering the citizen petition SUMMARY: The Office for Human Lane, Rm. 1061, Rockville, MD 20852. and reviewing Agency records and Research Protections (OHRP), Office of • For written/paper comments based on the information we have at this the Assistant Secretary for Health, and submitted to the Division of Dockets time, FDA has determined under the Food and Drug Administration Management, FDA will post your § 314.161 that SAMSCA (tolvaptan) (FDA) are announcing the availability of comment, as well as any attachments, tablets, 60 mg, were not withdrawn for a draft guidance entitled ‘‘Institutional except for information submitted, reasons of safety or effectiveness. The Review Board (IRB) Written Procedures: marked and identified, as confidential, petitioner has identified no data or other Guidance for Institutions and IRBs.’’ if submitted as detailed in information suggesting that SAMSCA The purpose of this draft guidance is to ‘‘Instructions.’’ (tolvaptan) tablets, 60 mg, were assist IRB administrators, IRB Instructions: All submissions received withdrawn for reasons of safety or chairpersons, and other institutional must include the Docket No. FDA– effectiveness. We have carefully officials responsible for preparing and 2016–D–1605 for ‘‘Institutional Review reviewed our files for records maintaining written procedures for Board (IRB) Written Procedures: concerning the withdrawal of SAMSCA IRBs. The draft guidance is intended for Guidance for Institutions and IRBs.’’ (tolvaptan) tablets, 60 mg, from sale. We IRBs and institutions responsible for Received comments will be placed in mstockstill on DSK3G9T082PROD with NOTICES have also independently evaluated review and oversight of human subject the docket and, except for those relevant literature and data for possible research under the HHS or FDA submitted as ‘‘Confidential postmarketing adverse events. We have regulations, or both. Submissions,’’ publicly viewable at reviewed the available evidence and DATES: Although you can comment on http://www.regulations.gov or at the determined that this drug product was any guidance at any time (see 21 CFR Division of Dockets Management not withdrawn from sale for reasons of 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday safety or effectiveness. considers your comment on this draft through Friday. VerDate Sep<11>2014 18:35 Aug 01, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\02AUN1.SGM 02AUN1


Document Created: 2016-08-02 01:48:01
Document Modified: 2016-08-02 01:48:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactChristopher Koepke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240- 402-3543.
FR Citation81 FR 50710 
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