Notice2022-14929
Determination That REGLAN Injection (Metoclopramide Injection, USP), Equivalent to 5 Milligrams Base/Milliliter and Equivalent to 10 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
July 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that REGLAN Injection (metoclopramide injection, USP), equivalent to (EQ) 5 milligrams (mg) base/milliliter (mL) and EQ 10 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 87 Issue 133 (Wednesday, July 13, 2022)</title>
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[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41729-41730]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14929]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0115]
Determination That REGLAN Injection (Metoclopramide Injection,
USP), Equivalent to 5 Milligrams Base/Milliliter and Equivalent to 10
Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of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 REGLAN Injection (metoclopramide injection, USP),
equivalent to (EQ) 5 milligrams (mg) base/milliliter (mL) and EQ 10 mg
base/mL, was not withdrawn from sale for reasons of safety or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: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6210, Silver Spring, MD 20993-0002, 301-
796-6650, <a href="/cdn-cgi/l/email-protection#cfabaea1a6aaa3e1a8a0bbbba3a6aaad8fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="c7a3a6a9aea2abe9a0a8b3b3abaea2a587a1a3a6e9afafb4e9a0a8b1">[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 FDA's approval of 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.
REGLAN Injection (metoclopramide injection, USP), EQ 5 mg base/mL
and EQ 10 mg base/mL, is the subject of NDA 017862, held by Hikma
Pharmaceuticals USA Inc., and initially approved on February 7, 1979
(EQ 5 mg base/mL) and May 28, 1987 (EQ 10 mg base/mL). REGLAN is
indicated for the relief of symptoms associated with acute and
recurrent diabetic gastric stasis, prophylaxis of vomiting associated
with emetogenic cancer therapy, and prophylaxis of postoperative nausea
and vomiting in those circumstances where nasogastric suction is
undesirable. REGLAN may also be used to facilitate small bowel
intubation in adults and pediatric patients in whom the tube does not
pass the pylorus with conventional maneuvers or to stimulate gastric
emptying and intestinal transit of barium in cases where delayed
emptying interferes with radiological examination of the stomach and/or
small intestine.
REGLAN Injection (metoclopramide injection, USP), EQ 5 mg base/mL
and EQ 10 mg base/mL, is currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
Baxter Healthcare Corp. submitted a citizen petition dated February
1, 2022 (Docket No. FDA-2022-P-0115), under 21 CFR 10.30, requesting
that the Agency determine whether REGLAN Injection (metoclopramide
injection, USP), 5 mg base/mL, was withdrawn from sale for reasons of
safety or effectiveness. Although the citizen petition did not address
the EQ 10 mg base/mL strength, that strength has also been
discontinued. On our own initiative, we have also determined whether
that strength was withdrawn for safety or effectiveness reasons.
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 REGLAN Injection (metoclopramide injection,
USP), EQ 5 mg base/mL and EQ 10 mg base/mL, was not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that this drug product was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of REGLAN
Injection (metoclopramide injection, USP), EQ 5 mg base/mL and EQ 10 mg
base/mL, from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
[[Page 41730]]
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 REGLAN Injection
(metoclopramide injection, USP), EQ 5 mg base/mL and EQ 10 mg base/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.
Dated: July 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14929 Filed 7-12-22; 8:45 am]
BILLING CODE 4164-01-P
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