INAPSINE Droperidol Injection Not Withdrawn for Safety - Generic Approval Pathway

Content

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has determined that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn
from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to
approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT:

Alexander Poonai, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,
Rm. 6213, Silver Spring, MD 20993-0002, 301-796-3600, alexander.poonai@fda.hhs.gov.

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reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety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withdrawn from sale for reasons of safety or effectiveness.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been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that does not refer to a listed drug.

INAPSINE (droperidol) injection, 2.5 mg/mL, is the subject of NDA 016796, held by Akorn, Inc., and initially approved on June
11, 1970. INAPSINE is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnosis procedure.

INAPSINE (droperidol) injection, 2.5 mg/mL, is currently listed in the “Discontinued Drug Product List” section of the Orange
Book.

Mr. Robert van Osdel submitted a citizen petition dated January 15, 2025 (Docket No. FDA-2025-P-0253), under 21 CFR 10.30,
requesting that the Agency determine whether INAPSINE (droperidol) injection, 2.5 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 § 314.161 that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other information suggesting that INAPSINE (droperidol) injection,
2.5 mg/mL was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning
the withdrawal of INAPSINE (droperidol) injection, 2.5 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 INAPSINE (droperidol) injection, 2.5 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. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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. 2026-06314 Filed 3-31-26; 8:45 am] BILLING CODE 4164-01-P

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