Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) has determined that PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 600 milligrams (mg)/2 milliliters (mL) (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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 pralidoxime chloride solution, 600 mg/2 mL (300 mg/mL), if all other legal and regulatory requirements are met.

Full Text

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<title>Federal Register, Volume 91 Issue 192 (Tuesday, October 6, 2026)</title>
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[Federal Register Volume 91, Number 192 (Tuesday, October 6, 2026)]
[Notices]
[Pages 63562-63563]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-P-3632]


Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime 
Chloride) Solution, 600 Milligrams/2 Milliliters (300 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Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or 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, Agency, or we) has 
determined that PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime 
chloride) solution, 600 milligrams (mg)/2 milliliters (mL) (300 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was not withdrawn from sale for reasons of safety or effectiveness.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 pralidoxime chloride solution, 600 mg/2 mL 
(300 mg/mL), if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, <a href="/cdn-cgi/l/email-protection#ca8bbda5e48bb8a9a2aba7baa5a4ade78db8abb38aacaeabe4a2a2b9e4ada5bc"><span class="__cf_email__" data-cfemail="26675149086754454e474b564948410b6154475f66404247084e4e5508414950">[email&#160;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

[[Page 63563]]

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.
    PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) 
solution, 600 mg/2 mL (300 mg/mL), is the subject of NDA 018986, held 
by Meridian Medical Technologies, Inc., and initially approved on April 
26, 1983. PRALIDOXIME CHLORIDE (AUTOINJECTOR) is indicated for intra-
muscular use as an adjunct to atropine in the treatment of poisoning by 
nerve agents having anticholinesterase activity.
    PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) 
solution, 600 mg/2 mL (300 mg/mL), is currently listed in the 
``Discontinued Drug Product List'' section of the Orange Book.
    Premier Research International, LLC, submitted a citizen petition 
dated March 25, 2026 (Docket No. FDA-2026-P-3632), under 21 CFR 10.30, 
requesting that the Agency determine whether PRALIDOXIME CHLORIDE 
(AUTOINJECTOR) (pralidoxime chloride) solution, 600 mg/2 mL (300 mg/
mL), has been voluntarily withdrawn 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 PRALIDOXIME CHLORIDE (AUTOINJECTOR) 
(pralidoxime chloride) solution, 600 mg/2 mL (300 mg/mL), was not 
withdrawn for reasons of safety or effectiveness. The petitioner has 
identified no data or other information suggesting that PRALIDOXIME 
CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 600 mg/2 mL 
(300 mg/mL), was withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 
600 mg/2 mL (300 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 PRALIDOXIME CHLORIDE 
(AUTOINJECTOR) (pralidoxime chloride) solution, 600 mg/2 mL (300 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 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.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20442 Filed 10-5-26; 8:45 am]
BILLING CODE 4164-01-P


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