[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30312-30313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons 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milliliters (mL), was not withdrawn from sale for reasons of safety or 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, [email protected].

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