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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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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.