Notice2026-06661
Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
April 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that STRATTERA (atomoxetine hydrochloride) capsules 5 milligrams, 10 milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, were not withdrawn from sale for reasons of safety or effectiveness.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
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<title>Federal Register, Volume 91 Issue 65 (Monday, April 6, 2026)</title>
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[Federal Register Volume 91, Number 65 (Monday, April 6, 2026)]
[Notices]
[Pages 17285-17286]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06661]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-6868]
Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules
5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40
Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 STRATTERA (atomoxetine hydrochloride) capsules 5
milligrams, 10 milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams,
60 Milligrams, 80 Milligrams, and 100 Milligrams, were not withdrawn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: Rana Carroll, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6218, Silver Spring, MD 20993-0002, 301-
796-6135, <a href="/cdn-cgi/l/email-protection#1547747b743b567467677a7979557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="1b497a757a35587a69697477775b7d7f7a35737368357c746d">[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.
STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10
Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams,
80 Milligrams, and 100 Milligrams, is the subject of NDA 021411, held
by Eli Lilly and Co, and initially approved on November 26, 2022.
STRATTERA is indicated for the treatment of Attention-Deficit/
Hyperactivity Disorder (ADHD).
In a letter dated August 5, 2025, Eli Lilly and Company notified
FDA that STRATTERA (Atomoxetine
[[Page 17286]]
Hydrochloride) Capsules 10 Milligrams, 18 Milligrams, 25 Milligrams, 40
Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligram, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Rosemont Pharmaceuticals Holdings, Inc submitted a citizen petition
dated December 4, 2025 (Docket No. FDA-2025-P-6868), under 21 CFR
10.30, requesting that the Agency determine whether STRATTERA
(Atomoxetine Hydrochloride) 10 Milligrams, 18 Milligrams, 25
Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100
Milligrams capsules were withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 5
Milligrams strength, that strength has also been discontinued. On our
own initiative, we have also determined whether that strength was
withdrawn for safety or effectiveness reasons.
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 STRATTERA (Atomoxetine Hydrochloride) 5
Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams,
60 Milligrams, 80 Milligrams, and 100 Milligrams capsules, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that STRATTERA
(Atomoxetine Hydrochloride) 5 Milligrams, 10 Milligrams, 18 Milligrams,
25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100
Milligrams capsules were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of STRATTERA (Atomoxetine Hydrochloride) 5
Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams,
60 Milligrams, 80 Milligrams, and 100 Milligrams capsules, 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 STRATTERA
(Atomoxetine Hydrochloride) 5 Milligrams, 10 Milligrams, 18 Milligrams,
25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100
Milligrams capsules, 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06661 Filed 4-3-26; 8:45 am]
BILLING CODE 4164-01-P
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