Eurand receives approval to market generic potassium chloride
Italian speciality pharmaceutical company Eurand has received final approval from the US FDA for its Abbreviated New Drug Application for potassium chloride 20mEq tablets.
Italian speciality pharmaceutical company Eurand has received final approval from the US FDA for its Abbreviated New Drug Application for potassium chloride 20mEq tablets.
Potassium chloride 20mEq is the generic version of Key Pharmaceutical's K-Dur 20 tablet, a potassium supplement used in the treatment of hypokalemia, digitalis intoxication and hypokalemic familial periodic paralysis. Eurand will license the product in the US to a marketing partner.
'Eurand's product utilises our Microcaps technology and will be our eighth product launched in the US using this innovative technology,' said Gearoid Faherty, ceo of Eurand.
'This product was developed by Eurand and is the first product in our internal product pipeline to be approved in the US.
'While Eurand's primary focus is on therapeutically unique products, we developed this ANDA product to support and expand our current KCl franchise,' he added.
Eurand develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. It specialises in bioavailability enhancement of poorly soluble drugs utilising its Biorise platform, modified release and taste masking and is currently developing a pipeline of products based on its proprietary technologies. Eurand also works with leading pharmaceutical and biotechnology companies to develop enhanced forms of their existing products and development compounds.