Ferring Statement on Minirin® / Octostim® / DDAVP® / Stimate® (desmopressin) Nasal Spray

Ferring Statement on Minirin® / Octostim® / DDAVP® / Stimate® (desmopressin) Nasal Spray
21 June 2022 celia

Ferring Statement on Minirin®/Octostim®/DDAVP®/Stimate® (desmopressin) Nasal Spray

Saint-Prex, Switzerland – 21 June, 2022 – Minirin® (desmopressin) Nasal Spray 0.1 mg/ml room temperature stable (RTS)/ Octostim® (desmopressin) Nasal Spray 1.5 mg/ml/ DDAVP® (desmopressin acetate, 10 mcg/0.1 mL)/ Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray/ Generic Desmopressin Acetate (10 mcg/0.1mL) Nasal Spray – Recall and Production Hold Statement

Following the detection of out-of-specification results during testing, in 2020 Ferring initiated a precautionary voluntary global recall of all batches of the following products:

  • Minirin® (desmopressin) Nasal Spray 0.1 mg/ml room temperature stable (RTS) formulation
  • Octostim® (desmopressin) Nasal Spray 1.5 mg/ml
  • DDAVP® (desmopressin acetate, 10 mcg/0.1 mL)
  • Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray
  • Generic Desmopressin Acetate (10 mcg/0.1mL) Nasal Spray

Following investigation, the root cause of the out-of-specification results was identified as a tightness issue with the primary packaging materials.

In order to resolve this issue, new machinery is required and a new assembly process will need to be designed and validated. Based on the timelines needed to procure, install and qualify a new production line, we expect to start manufacturing Minirin® Nasal Spray Room Temperature Stable (RTS) 0.1 mg/ml and Octostim® (desmopressin) Nasal Spray 1.5 mg/ml in Q2 of 2023. Dependent on regulatory submission and approval timelines, deliveries to first markets are now expected from mid-2024 due to additional stability data required.

Ferring is committed to ensuring that our medicines adhere to the highest quality standards for our patients, and to working with health authorities to ensure alternatives for patients. Any patients or caregivers with concerns or questions about treatment alternatives should immediately contact their treating physician.

If you have additional questions, please find contact details of regional Ferring teams below:

US and Canada
If you are based in the United States, please call our Medical Information line at 1-888-FERRING (1-888-337-7464) to discuss your question. You can also email MedQueriesUS@ferring.com.

If you are based in Canada, please contact info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.


Europe
If you are based in Europe, please contact info@ferring.com with your question and share your contact telephone number so that a member of your local team can contact you.


Asia-Pacific
If you are based in India, please contact medicaldesk.india@ferring.com and share your question and contact telephone number so that a member of the local team can contact you.

If you are based in other locations in Asia-Pacific, please contact info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.


Latin America
If you are based in Latin America, please contact info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.


Middle East and Africa
If you are based in the Middle East or Africa, please email info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.

This page is not intended for patients or for members of the general public. It is only intended to be used by healthcare professionals.

OK

Cette page n'est pas destinée aux patients ou au grand public. Il est uniquement destiné à être utilisé par des professionnels de santé.

OK

Ik bevestig dat ik een professionele zorgverlener ben of een zakelijke relatie heb met Ferring Pharmaceuticals

OK

Ez az oldal nem betegeknek, vagy nagyközönségnek szól. Az oldalt kizárólag egészségügyi szakemberek használhatják.

OK

Ta strona nie jest przeznaczona dla pacjentów ani dla ogółu odwiedzających. Ta strona stworzona jest dla pracowników sektora ochrony zdrowia.

OK

Эта страница не предназначена для пациентов или для широкой публики. Она предназначена только для медицинских работников.

OK