[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7046-7047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-4852]


Determination That LOTENSIN HCT (Benazepril Hydrochloride; 
Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 LOTENSIN HCT (benazepril hydrochloride; 
hydrochlorothiazide) oral tablets, 5 milligrams (mg) and 6.25 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not withdrawn from sale for reasons of safety or effectiveness.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 benazepril hydrochloride; hydrochlorothiazide 
oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[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

[[Page 7047]]

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.
    LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral 
tablets, 5 mg and 6.25 mg, are the subject of NDA 020033, held by U.S. 
Pharmaceutical Holdings I, LLC, and initially approved on May 19, 1992. 
LOTENSIN HCT is indicated for the relief of symptoms of depression. 
LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral 
tablets, 5 mg and 6.25 mg, are currently listed in the ``Discontinued 
Drug Product List'' section of the Orange Book.
    EAS Consulting Group, LLC submitted a citizen petition dated August 
9, 2017 (Docket No. FDA-2017-P-4852), under 21 CFR 10.30, requesting 
that the Agency determine whether LOTENSIN HCT (benazepril 
hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 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 LOTENSIN HCT (benazepril hydrochloride; 
hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn 
for reasons of safety or effectiveness. The petitioner has identified 
no data or other information suggesting that these products were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of LOTENSIN 
HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg 
and 6.25 mg, from sale. We have also independently evaluated relevant 
literature and data for possible post-marketing 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 LOTENSIN HCT 
(benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 
6.25 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 
LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral 
tablets, 5 mg and 6.25 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: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03188 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P


