```

[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Pages 91405-91406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26916]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-P-1991 and FDA-2021-P-0940]

Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) 
Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not 
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that HYDROCORTONE (hydrocortisone sodium phosphate) 
injection, equivalent to (EQ) 50 milligrams (mg) base/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was not withdrawn from sale for reasons of safety or effectiveness.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 HYDROCORTONE (hydrocortisone sodium phosphate) 
injection, EQ 50 mg base/mL, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Beth Holck, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 240-402-7133, 
[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 91406]]

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.
    HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg 
base/mL, is the subject of NDA 012052, held by Merck & Co., Inc., and 
initially approved on June 8, 1960. HYDROCORTONE (hydrocortisone sodium 
phosphate) injection, EQ 50 mg base/mL, is synthetic glucocorticoid for 
use as an anti-inflammatory or immunosuppressant agent.
    The indications for glucocorticoid drugs, including HYDROCORTONE 
(hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL (Merck 
Sharpe & Dohme (now Merck & Co., Inc.); NDA 012052) were reviewed for 
efficacy under the Drug Efficacy Study Implementation program. Under 
this program, which was implemented in response to the 1962 amendments 
to the FD&C Act requiring demonstration of effectiveness (Kefauver-
Harris Amendments of 1962 (Pub. L. 87-781)), the National Academy of 
Sciences-National Research Council (NAS-NRC) studied about 4,000 drug 
formulations to assess the efficacy of the drug products. Upon 
consideration of the findings and recommendations of the NAS-NRC, FDA 
set forth in the Federal Register its conclusions and assessment of 
whether and under what circumstances the reviewed drug products are 
considered ``effective'' for use as required by the FD&C Act. In the 
Federal Register of February 19, 1972 (37 FR 3775), FDA announced that 
preparations containing hydrocortisone sodium phosphate are effective 
or probably effective for parenteral use by the appropriate route of 
administration.
    FDA published a subsequent notice in the Federal Register of March 
1, 1977 (42 FR 11893), in which the Agency set forth the indications 
that it found to be effective for certain drug products, including for 
HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg 
base/mL (NDA 012052). The March 1, 1977, notice announced FDA was 
prepared to approve NDAs and supplements to previously approved NDAs 
under the conditions described in the notice, including the condition 
that the revised labeling include only the indications for which the 
drug was classified as effective set forth in that notice (42 FR 11893 
at 11894-5).
    HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg 
base/mL, is currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book. In a letter dated April 4, 2003, Merck & 
Co., Inc., notified FDA that HYDROCORTONE (hydrocortisone sodium 
phosphate) injection, EQ 50 mg base/mL, was discontinued effective 
September 20, 2002. In the same letter, Merck & Co., Inc., also 
requested withdrawal of NDA 012052 for HYDROCORTONE (hydrocortisone 
sodium phosphate), and FDA moved the drug product to the ``Discontinued 
Drug Product List'' section of the Orange Book. In the Federal Register 
of May 5, 2004 (69 FR 25124), FDA announced that it was withdrawing 
approval of NDA 012052, effective June 4, 2004.
    Hyman, Phelps & McNamara, P.C., submitted an initial citizen 
petition dated September 21, 2020 (Docket No. FDA-2020-P-1991) as well 
as a second citizen petition dated August 25, 2021 (Docket No. FDA-
2021-P-0940), under 21 CFR 10.30, requesting that the Agency determine 
whether HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 
mg base/mL, was withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petitions and reviewing Agency 
records and based on the information we have at this time, FDA has 
determined under Sec.  314.161 that HYDROCORTONE (hydrocortisone sodium 
phosphate) injection, EQ 50 mg base/mL, was not withdrawn for reasons 
of safety or effectiveness. The petitioner has identified no data or 
other information suggesting that HYDROCORTONE (hydrocortisone sodium 
phosphate) injection, EQ 50 mg base/mL, was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of HYDROCORTONE (hydrocortisone 
sodium phosphate) injection, EQ 50 mg base/mL, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have found no information that would 
indicate that this drug product was withdrawn from sale for reasons of 
safety or effectiveness.
    Accordingly, the Agency will continue to list HYDROCORTONE 
(hydrocortisone sodium phosphate) injection, EQ 50 mg base/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 HYDROCORTONE 
(hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, may be 
approved by the Agency if 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: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26916 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P
```