[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Milligram) Was Not Withdrawn From Sale for Reasons of Safety or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was not withdrawn from sale for reasons of safety or effectiveness.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FDA determines that the listed drug was withdrawn from sale for reasons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