[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41729-41730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14929]


-----------------------------------------------------------------------

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Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of 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.

-----------------------------------------------------------------------

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base/mL, was not withdrawn from sale for reasons of safety or 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, [email protected].

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