82 FR 41967 - Determination That ENJUVIA (Estrogens, Conjugated Synthetic B) Tablets, 0.625 Milligrams and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 82, Issue 170 (September 5, 2017)

The Food and Drug Administration (FDA or Agency) has determined that ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 milligrams (mg) and 1.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, if all other legal and regulatory requirements are met.

[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41967-41968]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-1459]


Determination That ENJUVIA (Estrogens, Conjugated Synthetic B) 
Tablets, 0.625 Milligrams and 1.25 Milligrams, Were Not Withdrawn From 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 ENJUVIA (estrogens, conjugated synthetic B) tablets, 
0.625 milligrams (mg) and 1.25 mg, were not withdrawn from sale for 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 ENJUVIA 
(estrogens, conjugated synthetic B) tablets, 0.625 mg and 1.25 mg, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-5092.

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.
    ENJUVIA (estrogens, conjugated synthetic B) tablets, 0.625 mg and 
1.25 mg, is the subject of NDA 021443, held by Teva Branded 
Pharmaceutical Products R&D, Inc. (Teva), and was initially approved on 
May 10, 2004. ENJUVIA is indicated for treatment of moderate to severe 
vasomotor symptoms due to menopause and treatment of moderate to severe 
vaginal dryness and pain with intercourse, as well as symptoms of 
vulvar and vaginal atrophy due to menopause.
    In 2016, Teva notified FDA that ENJUVIA (estrogens, conjugated 
synthetic B) tablets, 0.625 mg and 1.25 mg, were being discontinued, 
and FDA moved those drug products to the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Foley & Lardner submitted a citizen petition dated March 8, 2017 
(Docket No. FDA-2017-P-1459), under 21 CFR 10.30, requesting that the 
Agency determine whether ENJUVIA (estrogens, conjugated synthetic B) 
tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, conjugated synthetic B) 
tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, conjugated 
synthetic B) tablets, 0.625 mg and 1.25 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 these drug products were withdrawn from sale for reasons 
of safety or effectiveness.
    Accordingly, the Agency will continue to list ENJUVIA (estrogens, 
conjugated synthetic B) tablets, 0.625 mg and 1.25 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 ENJUVIA (estrogens, 
conjugated synthetic B) tablets, 0.625 mg and 1.25 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.


[[Page 41968]]


    Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18693 Filed 9-1-17; 8:45 am]
BILLING CODE 4164-01-P