[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50158-50159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-1574]


Determination That Progesterone Injection, USP, 50 Milligrams/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or 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 Progesterone Injection, USP, 50 milligrams/milliliter 
(mg/mL), was not withdrawn from sale for reasons of safety or 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: Iris Masucci, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-3600, 
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and

[[Page 50159]]

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.
    Progesterone Injection, USP, 50 mg/mL, is the subject of NDA 
017362, held by Actavis Laboratories UT, Inc., and initially approved 
on May 11, 1978. Progesterone Injection, USP, 50 mg/mL, is indicated in 
amenorrhea and abnormal uterine bleeding due to hormonal imbalance in 
the absence of organic pathology, such as submucous fibroids or uterine 
cancer. Progesterone Injection, USP, 50 mg/mL, is currently listed in 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Dar[eacute] Bioscience, Inc., submitted a citizen petition dated 
April 19, 2023 (Docket No. FDA-2023-P-1574), under 21 CFR 10.30, 
requesting that the Agency determine whether Progesterone Injection, 
USP, 50 mg/mL (NDA 017362), 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 Progesterone Injection, USP, 50 mg/mL, was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that Progesterone 
Injection, USP, 50 mg/mL, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of Progesterone Injection, USP, 50 mg/mL, 
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 Progesterone 
Injection, USP, 50 mg/mL, 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: July 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16228 Filed 7-31-23; 8:45 am]
BILLING CODE 4164-01-P


