Notice2024-06311
Determination That ISUPREL (Isoproterenol Hydrochloride) Injection, 0.2 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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we) has determined that ISUPREL (isoproterenol hydrochloride) injection, 0.2 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 59 (Tuesday, March 26, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Notices]
[Page 20980]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06311]
-----------------------------------------------------------------------
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Injection, 0.2 Milligrams per Milliliter, Was Not Withdrawn From Sale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.
-----------------------------------------------------------------------
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milligrams (mg)/milliliter (mL), was not withdrawn from sale for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, <a href="/cdn-cgi/l/email-protection#461023282f373327681532233127343206202227682e2e3568212930"><span class="__cf_email__" data-cfemail="abfdcec5c2dadeca85f8dfcedccad9dfebcdcfca85c3c3d885ccc4dd">[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.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 26, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.