Notice2023-10052
Determination That Hydrochlorothiazide Oral Solution, 50 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
May 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that hydrochlorothiazide oral solution, 50 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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
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<title>Federal Register, Volume 88 Issue 91 (Thursday, May 11, 2023)</title>
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[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30312-30313]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10052]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-2229]
Determination That Hydrochlorothiazide Oral Solution, 50
Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons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, Agency, or we) has
determined that hydrochlorothiazide oral solution, 50 milligrams (mg)/5
milliliters (mL), was not withdrawn from sale for reasons of safety or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: Alaina Kupperman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6215, Silver Spring, MD 20993-0002, 301-
796-2395, <a href="/cdn-cgi/l/email-protection#a5e4c9c4cccbc48beed0d5d5c0d7c8c4cbe5c3c1c48bcdcdd68bc2cad3"><span class="__cf_email__" data-cfemail="21604d40484f400f6a54515144534c404f614745400f4949520f464e57">[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
[[Page 30313]]
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.
Hydrochlorothiazide oral solution, 50 mg/5 mL, is the subject of
ANDA 088587, held by Roxane Laboratories Inc., and initially approved
on July 2, 1984. Hydrochlorothiazide is indicated for: (1) adjunctive
therapy in edema associated with congestive heart failure, hepatic
cirrhosis, and corticosteroid and estrogen therapy; (2) edema due to
various forms of renal dysfunction such as nephrotic syndrome, acute
glomerulonephritis, and chronic renal failure; and (3) the management
of hypertension either as the sole therapeutic agent or to enhance the
effectiveness of other antihypertensive drugs in the more severe form
of hypertension.
In a letter dated August 4, 2008, Roxane Laboratories Inc.
requested withdrawal of ANDA 088587 for hydrochlorothiazide oral
solution. In the Federal Register issue of July 21, 2010 (75 FR 42455),
FDA announced that it was withdrawing approval of ANDA 088587,
effective August 20, 2010.
Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
September 13, 2022 (Docket No. FDA-2022-P-2229), under 21 CFR 10.30,
requesting that the Agency determine whether hydrochlorothiazide oral
solution, 50 mg/5 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 hydrochlorothiazide oral solution, 50 mg/5 mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
this product was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of hydrochlorothiazide oral solution, 50 mg/5 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 hydrochlorothiazide
oral solution, 50 mg/5 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 this drug product 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: May 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10052 Filed 5-10-23; 8:45 am]
BILLING CODE 4164-01-P
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