Document ID: FDA-2022-P-0585-0004
Agency: fda
Document Type: Notice
Title: Determination That NORFLEX (Orphenadrine Citrate) Injection, 30 Milligrams/Milliliter, and NORFLEX (Orphenadrine Citrate) Extended-
Release Tablet, 100 Milligrams, Were Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
Posted Date: 2022-12-08T05:00Z

[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75278-75279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26663]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-0585]

Determination That NORFLEX (Orphenadrine Citrate) Injection, 30 
Milligrams/Milliliter, and NORFLEX (Orphenadrine Citrate) Extended-
Release Tablet, 100 Milligrams, Were Not Withdrawn From Sale for 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 NORFLEX (orphenadrine citrate) Injection, 30 milligrams 
(mg)/milliliter (mL), and NORFLEX (orphenadrine citrate) Extended-
Release Tablet, 100 mg, were not withdrawn from sale for reasons of 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: Anuj Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-796-2246, 
[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.
    NORFLEX (orphenadrine citrate) Injection, 30 mg/mL, is the subject 
of NDA 013055, held by Pai Holdings LLC DBA Pharmaceutical Associates 
Inc., and initially approved on October 2, 1960. NORFLEX (orphenadrine 
citrate) Extended-Release Tablet, 100 mg, is the subject of NDA 012157, 
held by Bausch Health US LLC, and initially approved on November 2, 
1959. Both NORFLEX drug products are indicated as an adjunct to rest, 
physical therapy, and other measures for the relief of discomfort 
associated with acute painful musculoskeletal conditions.
    Both NORFLEX (orphenadrine citrate) Injection, 30 mg/mL, and 
NORFLEX (orphenadrine citrate) Extended-Release Tablet, 100 mg, are 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book.
    Odin Pharmaceuticals, LLC, submitted a citizen petition dated April 
11, 2022 (Docket No. FDA-2022-P-0585), under 21 CFR 10.30, requesting 
that the Agency determine whether NORFLEX (orphenadrine citrate) 
Injection, 30 mg/mL, was withdrawn from sale for reasons of safety or 
effectiveness. Although the citizen petition did not address the 100 mg 
extended-release tablet, that dosage form and strength has also been 
discontinued. On our own initiative, we have also determined whether 
that dosage form and 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 NORFLEX (orphenadrine citrate) Injection, 30 
mg/mL, and NORFLEX (orphenadrine citrate) Extended-Release Tablet, 100 
mg, were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
these drug products were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of NORFLEX (orphenadrine citrate) Injection, 
30 mg/mL, and NORFLEX (orphenadrine citrate) Extended-Release Tablet, 
100 mg, 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 these drug products were 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list NORFLEX (orphenadrine 
citrate) Injection, 30 mg/mL, and NORFLEX (orphenadrine citrate) 
Extended-Release Tablet, 100 mg, 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

[[Page 75279]]

current standards, the Agency will advise ANDA applicants to submit 
such labeling.

    Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26663 Filed 12-7-22; 8:45 am]
BILLING CODE 4164-01-P