[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Pages 15250-15251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06043]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-4293]
Determination That NASCOBAL (Cyanocobalamin) Nasal Spray, 0.5
Milligram/Spray, Was Not Withdrawn From Sale for Reasons of Safety or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, Agency, or we) has
determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram
(mg)/spray, was not withdrawn from sale for reasons of safety or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: Helen Ryan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-796-1328,
[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
[[Page 15251]]
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
(Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does
not refer to a listed drug.
NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, is the subject
of NDA 021642, held by Endo Operations Ltd., and initially approved on
January 31, 2005. NASCOBAL is a vitamin B12 indicated for vitamin B12
maintenance therapy in adult patients with pernicious anemia who are in
remission following intramuscular vitamin B12 therapy and who have no
nervous system involvement; treatment of adult patients with dietary,
drug-induced, or malabsorption-related vitamin B12 deficiency not due
to pernicious anemia; and prevention of vitamin B12 deficiency in adult
patients with vitamin B12 requirements in excess of normal.
In a letter dated July 26, 2024, Endo Operations Ltd. notified FDA
that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Robert van Osdel submitted a citizen petition dated September 7,
2024 (Docket No. FDA-2024-P-4293), under 21 CFR 10.30, requesting that
the Agency determine whether NASCOBAL (cyanocobalamin) nasal spray, 0.5
mg/spray, 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 Sec. 314.161 that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/
spray, 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 NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg/spray, 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 this drug product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NASCOBAL
(cyanocobalamin) nasal spray, 0.5 mg/spray, 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: March 31, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06043 Filed 4-8-25; 8:45 am]
BILLING CODE 4164-01-P