Notice2021-17990
Determination That ORTHO-CEPT (Desogestrel-Ethinyl Estradiol) 21- and 28-Day Oral Tablets, 0.15 Milligram/0.03 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
August 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28- day oral tablets, 0.15 milligram (mg)/0.03 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 86 Issue 160 (Monday, August 23, 2021)</title>
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[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47118-47119]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17990]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0292]
Determination That ORTHO-CEPT (Desogestrel-Ethinyl Estradiol) 21-
and 28-Day Oral Tablets, 0.15 Milligram/0.03 Milligram, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we) has
determined that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-
day oral tablets, 0.15 milligram (mg)/0.03 mg, were not withdrawn from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: 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,
<a href="/cdn-cgi/l/email-protection#93c0e7f2f0eabdd8f2fdf6d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="ecbf988d8f95c2a78d8289ac8a888dc284849fc28b839a">[email protected]</span></a>.
[[Page 47119]]
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and, with certain exceptions, labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28-day oral
tablets, 0.15 mg/0.03 mg, is the subject of NDA 020301, held by Janssen
Pharmaceuticals, Inc., and initially approved on December 14, 1992.
ORTHO-CEPT is indicated for the prevention of pregnancy in women who
elect to use oral contraceptives as a method of contraception.
In a letter dated October 7, 2014, Janssen Pharmaceuticals, Inc.,
notified FDA that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and
28-day oral tablets, 0.15 mg/0.03 mg, were being discontinued, and FDA
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
Arnall Golden Gregory LLP submitted a citizen petition dated March
11, 2021 (Docket No. FDA-2021-P-0292), under 21 CFR 10.30, requesting
that the Agency determine whether ORTHO-CEPT (desogestrel-ethinyl
estradiol) oral tablets, 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 ORTHO-CEPT (desogestrel-ethinyl estradiol) 21-
and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that ORTHO-CEPT (desogestrel-
ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/
0.03 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 ORTHO-CEPT
(desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/
0.03 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: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17990 Filed 8-20-21; 8:45 am]
BILLING CODE 4164-01-P
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