Desmopressin Newbury approved by the Swedish Health Authorities
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Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Läkemedel & Handel |
2023-07-19 11:30:00
Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Desmopressin Newbury 60, 120 & 240 mcg sublingual tablets in Sweden as the first country in a Scandinavian registration procedure. Approvals in Norway and Denmark are expected to follow upon finalized national reviews.
“Our niche peptide product has been developed based on the reference brand Minirin Melt from Ferring which is indicated for the treatment of diabetes insipidus, primary nocturnal enuresis and nocturia. Newbury is one of very few companies offering this complex niche peptide product which demonstrates our ability to provide highly differentiated, value-added niche products for our markets. Based on this positive progress, we will proceed to launch this product, within respective markets as soon as regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.
Nocturia is defined as “the complaint that the individual has to wake at night one or more times for voiding (i.e. to urinate)”. Nocturia becomes more common with age. More than 50 percent of men and women over the age of 60 have been measured to have nocturia in many communities.
The brand sold over €10 mio in Scandinavia between June 2022 and May 2023, according to DLMI.