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Pharmaceutical excipient for instant-release tablet coatings approved in USA

FDA authorizes use of Kollicoat® IR

(PresseBox) (Ludwigshafen, )
The US Food and Drug Administration (FDA) has approved the use of the pharmaceutical excipient Kollicoat IR for instant-release tablet coatings. The decision was made following the registration of Ibuprofen tablets coated with Kollicoat IR in an abbreviated application process (ANDA 75-661). It was the first time a regulatory safety evaluation of the new polyvinyl alcohol-polyethylene glycol graft copolymer was carried out in the USA. Both the functionality and safety of Kollicoat IR received a positive assessment.

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