[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50710-50711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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not withdrawn from sale for reasons of safety or effectiveness.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drug was withdrawn from sale for reasons of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