Notice2021-11802
Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
June 7, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness.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 QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 86 Issue 107 (Monday, June 7, 2021)</title>
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[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30320-30321]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-11802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-P-2317]
Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine
Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/
Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale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 or Agency) has
determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride)
Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/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was not withdrawn from sale for reasons of safety or effectiveness.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 QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, <a href="/cdn-cgi/l/email-protection#034d6a606c6f662d4e76666f6f6671436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="87c9eee4e8ebe2a9caf2e2ebebe2f5c7e1e3e6a9efeff4a9e0e8f1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
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.
QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, is the subject of NDA 008845, held by
Hospira, Inc., and initially approved on May 1, 1953. QUELICIN
PRESERVATIVE FREE is indicated as an adjunct to general anesthesia, to
facilitate tracheal intubation, and to provide skeletal muscle
relaxation during surgery or mechanical ventilation.
Baxter Healthcare Corp. submitted a citizen petition dated December
21, 2020 (Docket No. FDA-2020-P-2317), under 21 CFR 10.30, requesting
that the Agency determine whether QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 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 QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was not
withdrawn for reasons of safety or
[[Page 30321]]
effectiveness. The petitioner has identified no data or other
information suggesting that QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of QUELICIN PRESERVATIVE
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100
mg/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 QUELICIN PRESERVATIVE
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100
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
QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/
mL, 50 mg/mL, and 100 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: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11802 Filed 6-4-21; 8:45 am]
BILLING CODE 4164-01-P
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