Desmopressin Acetate Nasal Spray Shortage

• • DDAVP nasal spray, Ferring, 10 mcg/0.1 mL, 5 mL bottle, NDC 55566-2500-00
  • Stimate nasal spray, Ferring, 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 - discontinued
  • Desmopressin Acetate nasal spray, Sun Pharma, 10 mcg/0.1 mL, 5 mL bottle, NDC 47335-0788-91 - discontinued
  • Desmopressin Acetate nasal spray, Zydus, 10 mcg/0.1 mL, 5 mL bottle, NDC 68382-0384-01 - discontinued

• • In August 2020, Ferring recalled DDAVP nasal spray, desmopressin nasal spray, and Stimate nasal spray due to higher desmopressin amounts than specified. 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.
  • Amring has discontinued desmopressin nasal spray.
  • Apotex has desmopressin nasal spray available.
  • Bausch Health has desmopressin acetate nasal spray available.
  • Sun Pharma discontinued desmopressin acetate nasal spray.
  • Zydus discontinued desmopressin nasal spray in mid-December 2022.

• • Desmopressin Acetate nasal spray, Apotex, 10 mcg/0.1 mL, 5 mL bottle, NDC 60505-0815-00
  • Desmopressin Acetate nasal spray, Bausch Health, 10 mcg/0.1 mL, 5 mL bottle, NDC 24208-0342-05

Estimated Resupply Dates

• • Ferring 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.

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]

References

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