Notice2025-22680
Determination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
December 12, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
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[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Notices]
[Pages 57767-57768]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22680]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-2952]
Determination That LUNELLE (Estradiol Cypionate and
Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter
and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for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
[[Page 57768]]
determined that LUNELLE (estradiol cypionate and medroxyprogesterone
acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol
cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for estradiol cypionate and medroxyprogesterone
acetate injectable, 5 mg/0.5 mL estradiol cypionate and 25 mg/0.5 mL
medroxyprogesterone acetate, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Grace St.Vincent, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 240-
402-9201, <a href="/cdn-cgi/l/email-protection#175065767472394463417e797472796357717376397f7f6439707861"><span class="__cf_email__" data-cfemail="7a3d081b191f54290e2c1314191f140e3a1c1e1b54121209541d150c">[email protected]</span></a>.
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.
LUNELLE (estradiol cypionate and medroxyprogesterone acetate)
injectable, 5 mg/0.5 mL estradiol cypionate and 25 mg/0.5 mL
medroxyprogesterone acetate, is the subject of NDA 020874, held by
Pharmacia and Upjohn Co., and initially approved on October 5, 2000.
LUNELLE is indicated for the prevention of pregnancy.
In a letter dated June 24, 2003, Pharmacia and Upjohn Co. requested
withdrawal of NDA 020874 for LUNELLE (estradiol cypionate and
medroxyprogesterone acetate) injectable, 5 mg/0.5 mL estradiol
cypionate and 25 mg/0.5 mL medroxyprogesterone acetate. In the Federal
Register of May 5, 2004 (69 FR 25124), FDA announced that it was
withdrawing approval of NDA 020874, effective June 4, 2004.
Sarah A. Norring, Ph.D. submitted a citizen petition dated June 20,
2024 (Docket No. FDA-2024-P-2952), under 21 CFR 10.30, requesting that
the Agency determine whether LUNELLE (estradiol cypionate and
medroxyprogesterone acetate) injectable, 5 mg/0.5 mL estradiol
cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, 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 LUNELLE (estradiol cypionate and
medroxyprogesterone acetate) injectable, 5 mg/0.5 mL estradiol
cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not
withdrawn for reasons of safety or effectiveness. The petitioner
provided information about a voluntary recall of prefilled syringes of
LUNELLE in October 2002 due to potential manufacturing issues at a
particular facility. We have carefully reviewed our files for records
concerning the withdrawal of LUNELLE (estradiol cypionate and
medroxyprogesterone acetate) injectable, 5 mg/0.5 mL estradiol
cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, 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 LUNELLE (estradiol
cypionate and medroxyprogesterone acetate) injectable, 5 mg/0.5 mL
estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, 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 LUNELLE (estradiol
cypionate and medroxyprogesterone acetate) injectable, 5 mg/0.5 mL
estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, 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.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22680 Filed 12-11-25; 8:45 am]
BILLING CODE 4164-01-P
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