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Dipharma Gains European Approval of Generic Zavesca

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Thursday, February 21, 2019

Swiss generic drugmaker Dipharma  announced that the European Commission has granted Marketing Authorization of its generic miglustat.

This authorization comes after the European Medicines Agency’s the Committee for Medicinal Products for Human Use (CHMP) positive opinion last December in the frame of a centralized procedure. Miglustat Dipharma 100mg capsules has thus received authorization for all the 31 countries of the European Economic Area.

Miglustat Dipharma is a generic equivalent to Johnson & Johnson (NYSE: JNJ) company Actelion’s Zavesca (miglustat), and it can be stored at room temperature for 36 months. Dipharma owns IP rights on the miglustat active substance, notably in the USA and Europe.

“After our partner, Amerigen Pharmaceuticals Limited, successfully launched the first generic formulation of miglustat in the United States of America 10 months ago, we are now proud to bring this product to the European patients,” said Marc-Olivier Geinoz, chief executive of Dipharma.

In the European Union Zavesca was first approved in November 2002 for the treatment of type 1 Gaucher Disease and in January 2009 it obtained authorization for the treatment of Niemann-Pick disease type C, both before Actelion was acquired by J&J in 2017.

Source: Dipharma
3.75
3.8 from 4 votes
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