[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41273-41274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-1461]


Determination That CENESTIN (Estrogens, Conjugated Synthetic A) 
Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 
Milligrams, and 1.25 Milligrams, Were Not Withdrawn From Sale for 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 CENESTIN (estrogens, conjugated synthetic A) Tablets, 
0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9

[[Page 41274]]

mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or 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 these products, 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.
    CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 mg, 0.45 
mg, 0.625 mg, 0.9 mg, and 1.25 mg, is the subject of NDA 020992, held 
by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), and was 
initially approved on March 24, 1999. CENESTIN is indicated for 
treatment of moderate to severe vasomotor symptoms due to menopause and 
treatment of moderate to severe symptoms of vulvar and vaginal atrophy 
due to menopause.
    In 2016, Teva notified FDA that CENESTIN (estrogens, conjugated 
synthetic A) Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, 
were being discontinued, and FDA moved the drug product 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-1461), under 21 CFR 10.30, requesting that the 
Agency determine whether CENESTIN (estrogens, conjugated synthetic A) 
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were withdrawn 
from sale for reasons of safety or effectiveness.
    After considering the citizen and reviewing Agency records and 
based on the information we have at this time, FDA has determined under 
Sec.  314.161 that CENESTIN (estrogens, conjugated synthetic A) 
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 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 
these products 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 CENESTIN (estrogens, 
conjugated synthetic A) Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 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 
CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 mg, 0.45 mg, 
0.625 mg, 0.9 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.

    Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18376 Filed 8-29-17; 8:45 am]
 BILLING CODE 4164-01-P