[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Notices]
[Pages 39100-39101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-0069]


Determination That MICRONOR (Norethindrone Tablets, 0.35 
Milligram) Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that MICRONOR (norethindrone tablets, 0.35 milligram (mg)) 
was not withdrawn from sale for reasons of safety or effectiveness. 
This

[[Page 39101]]

determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for norethindrone tablets, 0.35 mg, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [email protected].

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FDA determines that the listed drug was withdrawn from sale for reasons 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 FDA's approval of 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.
    MICRONOR (norethindrone tablets, 0.35 mg) is the subject of NDA 
016954, held by Janssen Pharmaceuticals Inc. (Janssen), and initially 
approved on January 2, 1973. MICRONOR is indicated for the prevention 
of pregnancy.
    In a document dated June 6, 2018, Janssen notified FDA that the 
decision to withdraw MICRONOR (norethindrone tablets, 0.35 mg) from 
sale was based on business reasons and not for reasons of safety or 
efficacy. FDA moved the drug product to the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Aurobindo Pharma USA, Inc., submitted a citizen petition dated 
January 11, 2022 (Docket No. FDA-2022-P-0069), under 21 CFR 10.30, 
requesting that the Agency determine whether MICRONOR (norethindrone 
tablets, 0.35 mg) was 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 MICRONOR (norethindrone tablets, 0.35 mg) was 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that MICRONOR 
(norethindrone tablets, 0.35 mg) was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of MICRONOR (norethindrone tablets, 0.35 mg) 
from sale. We have also independently evaluated relevant literature and 
data for possible postmarketing adverse events. We have reviewed the 
available evidence and determined that this drug product was not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MICRONOR 
(norethindrone tablets, 0.35 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 MICRONOR (norethindrone tablets, 
0.35 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: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13958 Filed 6-29-22; 8:45 am]
BILLING CODE 4164-01-P


