[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47118-47119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Withdrawn From Sale for Reasons of Safety or Effectiveness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day oral tablets, 0.15 milligram (mg)/0.03 mg, were not withdrawn from 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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