Notice2022-20195
Determination That ENDEP (Amitriptyline Hydrochloride) Oral Concentrate, 40 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
September 19, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that ENDEP (amitriptyline hydrochloride) oral concentrate, 40 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 87 Issue 180 (Monday, September 19, 2022)</title>
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[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Notices]
[Pages 57202-57203]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20195]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0068]
Determination That ENDEP (Amitriptyline Hydrochloride) Oral
Concentrate, 40 Milligrams/Milliliter, Was Not Withdrawn From Sale for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 ENDEP (amitriptyline hydrochloride) oral concentrate,
40 milligrams (mg)/milliliter (mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for ENDEP
(amitriptyline hydrochloride) oral concentrate, 40 mg/mL, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
[[Page 57203]]
Silver Spring, MD 20993-0002, 301-796-1546,
<a href="/cdn-cgi/l/email-protection#0942686c7d666a61602746626c646e6b66496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="a0ebc1c5d4cfc3c8c98eefcbc5cdc7c2cfe0c6c4c18ec8c8d38ec7cfd6">[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.
ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, is
the subject of ANDA 085749, held by Hoffman-La Roche Inc., and
initially approved on December 23, 1977. ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL, is indicated for relief of
symptoms of depression.
Hoffman-La Roche Inc. has never marketed ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL. ANDA 085749 is listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
January 11, 2022 (Docket No. FDA-2022-P-0068), under 21 CFR 10.30,
requesting that the Agency determine whether ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 mg/mL, 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 ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ENDEP (amitriptyline hydrochloride) oral
concentrate, 40 mg/mL, 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 ENDEP (amitriptyline
hydrochloride) oral concentrate, 40 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. ANDAs that refer to ENDEP (amitriptyline hydrochloride)
oral concentrate, 40 mg/mL, 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: September 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20195 Filed 9-16-22; 8:45 am]
BILLING CODE 4164-01-P
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