90 FR 67 pgs. 15250-15251 - Determination That NASCOBAL (Cyanocobalamin) Nasal Spray, 0.5 Milligram/Spray, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 90Number: 67Pages: 15250 - 15251
Pages: 15250, 15251Docket number: [Docket No. FDA-2024-P-4293]
FR document: [FR Doc. 2025-06043 Filed 4-8-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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Determination That NASCOBAL (Cyanocobalamin) Nasal Spray, 0.5 Milligram/Spray, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.
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(FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness.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, helen.ryan@fda.hhs.gov.
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).
[top] 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
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 (§?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 §?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