[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Page 20980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-4636]


Determination That ISUPREL (Isoproterenol Hydrochloride) 
Injection, 0.2 Milligrams per Milliliter, Was Not Withdrawn From Sale 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, Agency, or we) has 
determined that ISUPREL (isoproterenol hydrochloride) injection, 0.2 
milligrams (mg)/milliliter (mL), was not withdrawn from sale for 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 ISUPREL 
(isoproterenol hydrochloride) injection, 0.2 mg/mL, if all other legal 
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Veniqua Stewart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3627, [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 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.
    ISUPREL (isoproterenol hydrochloride) injection, 0.2 mg/mL, is the 
subject of NDA 010515, held by Bausch Health US, LLC, and was initially 
approved on May 25, 1956. ISUPREL injection is indicated to improve 
hemodynamic status in patients in distributive shock and shock due to 
reduced cardiac output, and is also indicated for bronchospasm 
occurring during anesthesia. ISUPREL (isoproterenol hydrochloride) 
injection, 0.2 mg/mL, is currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book.
    E. Rust Consulting, LLC submitted a citizen petition dated October 
20, 2023 (Docket No. FDA-2023-P-4636), under 21 CFR 10.30, requesting 
that the Agency determine whether ISUPREL (isoproterenol hydrochloride) 
injection, 0.2 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 ISUPREL (isoproterenol hydrochloride) 
injection, 0.2 mg/mL, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that ISUPREL (isoproterenol hydrochloride) 
injection, 0.2 mg/mL, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of ISUPREL (isoproterenol hydrochloride) 
injection, 0.2 mg/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 ISUPREL 
(isoproterenol hydrochloride) injection, 0.2 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 ISUPREL 
(isoproterenol hydrochloride) injection, 0.2 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: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06311 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P