Indigene Pharmaceuticals was able to support claims that its dietary supplement Relaxane relieves stress symptoms, the National Advertising Division concludes Dec 20. NAD evaluated three claims, including one that the product "is designed to provide stress relief and address multiple symptoms of stress." In support of its claims, the firm presented three clinical studies as well as two post-marketing surveys. NAD concluded it was "satisfied that the challenged advertising clearly conveys that Relaxane is for, and has been tested for, relief and alleviation of the symptoms associated with stress"...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.