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10/12/2020

Desmopressin Acetate Nasal Spray

Products Affected - Description

    • DDAVP nasal spray, Ferring, 10 mcg/0.1 mL, 5 mL bottle, NDC 55566-2500-00
    • Noctiva nasal spray, Avadel, 0.83 mcg/0.1 mL, 3.8 mL bottle, NDC 71758-0106-55
    • Noctiva nasal spray, Avadel, 1.66 mcg/0.1 mL, 3.8 mL bottle, NDC 71758-0107-55
    • Stimate nasal spray, CSL Behring, 150 mcg/0.1 mL, 2.5 mL bottle, NDC 00053-6871-00
    • Desmopressin Acetate nasal spray, Amring Pharmaceuticals, 10 mcg/0.1 mL, 5 mL bottle, NDC 69918-0501-05
    • Desmopressin Acetate nasal spray, Zydus, 10 mcg/0.1 mL, 5 mL bottle, NDC 68382-0384-01

Reason for the Shortage

    • In August 2020, Ferring recalled DDAVP nasal spray, desmopressin nasal spray, and Stimate nasal spray due to higher desmopressin amounts than specified. Ferring manufactures Stimate and CSL Behring distributes it. Additional information is available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate#:~:text=Ferring%20Pharmaceuticals%20US%20is%20voluntarily,below%20to%20the%20consumer%20level.
    • Avadel did not provide a reason for the shortage of Noctiva.
    • Bausch Health and Sun Pharma have desmopressin acetate nasal spray available.
    • Zydus did not provide a reason for the shortage.

Available Products

    • Desmopressin Acetate nasal spray, Bausch Health, 10 mcg/0.1 mL, 5 mL bottle, NDC 24208-0342-05
    • Desmopressin Acetate nasal spray, Sun Pharma, 10 mcg/0.1 mL, 5 mL bottle, NDC 47335-0788-91

Estimated Resupply Dates

    • Avadel has Noctiva nasal spray on back order and the company cannot estimate a release date.
    • Amring (the generic division of Ferring) has desmopressin nasal spray on back order and the company cannot estimate a release date.
    • CSL Behring has Stimate nasal spray on back order and the company cannot estimate a release date.
    • Ferring has DDAVP nasal spray on back order and the company cannot estimate a release date.
    • Zydus has desmopressin nasal spray on back order and the company estimates a release date in late-October 2020.

Implications for Patient Care

    • Stimate contains a higher concentration of desmopressin per spray (150 mcg/actuation) than other desmopressin nasal spray products. It is approved for use in hemophilia A and in mild to moderate Type I von Willebrand's disease with Factor VIII levels greater than 5%.[1]
    • Desmopressin nasal spray 10 mcg/actuation is labeled for use as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and children 4 years of age and older.[1]
    • Noctiva nasal spray is labeled for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.[1]

References

    1. Desmopressin. Lexi-Drugs Online. Hudson, OH: Lexi-Comp Inc; 2020.

Updated

Updated October 12, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created August 14, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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