[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Page 37953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-0813]


Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1 
Milligram, 2 Milligrams, and 3 Milligrams, Was Not Withdrawn From Sale 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 TENEX (guanfacine hydrochloride) tablets, 1 milligram 
(mg), 2 mg, and 3 mg, was not withdrawn from sale for reasons of safety 
or effectiveness. This determination means that FDA will not begin 
procedures to withdraw approval of abbreviated new drug applications 
(ANDAs) that refer to this drug product, and it will allow FDA to 
continue to approve ANDAs that refer to the product as long as they 
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Jessica Tierney, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-9120, [email protected].

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.
    TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is 
the subject of NDA 019032, held by Promius Pharma LLC, and initially 
approved on October 27, 1996. TENEX is indicated in the management of 
hypertension.
    TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book. Unichem Pharmaceuticals (USA), Inc. submitted a 
citizen petition dated February 13, 2020 (Docket No. FDA-2020-P-0813), 
under 21 CFR 10.30, requesting that the Agency determine whether TENEX 
(guanfacine hydrochloride) tablets, 1 mg and 2 mg, was withdrawn from 
sale for reasons of safety or effectiveness. Although the citizen 
petition did not address the 3 mg strength, that strength has also been 
discontinued. On our own initiative, we have also determined whether 
that strength was withdrawn for safety or effectiveness reasons.
    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 TENEX (guanfacine hydrochloride) tablets, 1 
mg, 2 mg, and 3 mg, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that TENEX (guanfacine hydrochloride) tablets, 1 
mg, 2 mg, and 3 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of TENEX (guanfacine hydrochloride) tablets, 
1 mg, 2 mg, and 3 mg, from sale. We have also independently evaluated 
relevant literature and data for possible postmarketing adverse events. 
We have found no information that would indicate that this drug product 
was withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list TENEX (guanfacine 
hydrochloride) tablets, 1 mg, 2 mg, and 3 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also 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: June 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13594 Filed 6-23-20; 8:45 am]
BILLING CODE 4164-01-P