Notice2023-16228
Determination That Progesterone Injection, USP, 50 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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(FDA or Agency) has determined that Progesterone Injection, USP, 50 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 146 (Tuesday, August 1, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50158-50159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16228]
-----------------------------------------------------------------------
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Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or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.
-----------------------------------------------------------------------
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(mg/mL), was not withdrawn from sale for reasons of safety or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,
<a href="/cdn-cgi/l/email-protection#92dbe0fbe1bcdff3e1e7f1f1fbd2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="5d142f342e73103c2e283e3e341d3b393c7335352e733a322b">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 1, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.