[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Page 42101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18816]
[[Page 42101]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-2675]
Determination That GYNOREST (Dydrogesterone) Oral Tablets, 5
Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons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 GYNOREST (dydrogesterone) oral tablets, 5 milligrams
(mg) and 10 mg, were not withdrawn from sale for reasons of safety or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 GYNOREST (dydrogesterone) oral
tablets, 5 mg and 10 mg, if all other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT: Stefanie Kraus, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 301-
796-9585.
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drug was withdrawn from sale for reasons of safety or effectiveness (21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.
GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, are the
subject of NDA 017388, held by Solvay Pharmaceuticals (Solvay), and
initially approved on October 31, 1978. GYNOREST is indicated for
amenorrhea and abnormal uterine bleeding due to hormonal imbalance in
the absence of organic pathology, such as submucous fibroids or uterine
cancer.
Solvay never marketed GYNOREST (dydrogesterone) oral tablets, 5 mg
and 10 mg, under NDA 017388.\1\ In previous instances (see e.g., 72 FR
9763, March 5, 2007, and 61 FR 25497, May 21, 1996), the Agency has
determined that, for purposes of Sec. Sec. 314.61 and 314.162, never
marketing an approved drug product is equivalent to withdrawing the
drug from sale. In a letter dated June 1, 1992, Solvay requested
withdrawal of NDA 017388 for GYNOREST (dydrogesterone) oral tablets, 5
mg and 10 mg. In the Federal Register of June 25, 1993 (58 FR 34466),
FDA announced that it was withdrawing approval of NDA 017388, effective
July 26, 1993.
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\1\ GYNOREST was marketed in the United States under a
supplement to NDA 012985 for DUPHASTON (dydrogesterone, oral
tablets). Distribution of GYNOREST under the DUPHASTON NDA
discontinued around 1981.
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Foley and Lardner LLP submitted a citizen petition dated September
7, 2016 (Docket No. FDA-2016-P-2675), under 21 CFR 10.30, requesting
that the Agency determine whether GYNOREST (dydrogesterone) oral
tablets, 5 mg and 10 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 GYNOREST (dydrogesterone) oral
tablets, 5 mg and 10 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner states that GYNOREST (dydrogesterone)
oral tablets, 5 mg and 10 mg, were not withdrawn for reasons of safety
and effectiveness because the active pharmaceutical ingredient
dydrogesterone and the drug product dydrogesterone tablets have a
monograph in the current United States Pharmacopeia, public information
indicates that Solvay discontinued the product for commercial reasons,
there has been no notice in the Federal Register reflecting an Agency
determination that the product was withdrawn for reasons of safety or
effectiveness, and dydrogesterone oral tablets are being sold in many
other countries.
We have carefully reviewed our files for records concerning the
withdrawal of GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 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 GYNOREST
(dydrogesterone) oral tablets, 5 mg and 10 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 GYNOREST (dydrogesterone) oral
tablets, 5 mg and 10 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 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18816 Filed 9-5-17; 8:45 am]
BILLING CODE 4164-01-P