המידע באדיבות מדיקונטקסט
Last Updated: 2001-07-26 11:49:40 EDT (Reuters Health)
NEW YORK (Reuters Health) – Akzo Nobel NV's Organon has gained permission from the Dutch Medicines Evaluation Board to sell its fast-dissolve oral antidepressant Remeron (mirtazapine) SolTab, CIMA said on Thursday.
This regulatory action represents the drug's first European approval and triggers mutual recognition by other EU member states.
CIMA developed the technology that allows Remeron to dissolve on the tongue in 30 seconds, with or without water, and is the exclusive supplier of the fast-dissolve version of Remeron to West Orange, New Jersey-based Organon.
CIMA, based in Eden, Minnesota, produces five branded products that incorporate its fast-dissolve OraSolv and DuraSolv platforms, it said.
Remeron SolTab is already approved for sale in the US, where it hit the market in this year's first quarter. In January, Organon said that its product would be the first disintegrating antidepressant tablet to be commercially available.
Remeron, a 5HT-1A agonist, was first approved in the US in 1996.
In late-morning trade on the NASDAQ exchange, CIMA shares jumped 5.60, over 10%, to 59.60, and Akzo shares inched up 0.21 to 41.02 on Thursday.
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