[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Release Tablet, 100 Milligrams, Were Not Withdrawn From Sale for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Release Tablet, 100 mg, were not withdrawn from sale for reasons of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