Tavist-D for colds: TV advertising for Sandoz' OTC clemastine fumerate allergy medication touts the recent recommendation by FDA's Nonprescription and Pulmonary-Allergy Drugs Advisory Committees that the ingredient be approved for the treatment of the common cold. FDA has not approved a cold indication for Tavist-D and Sandoz did not have an NDA on file when the recommendation was made ("The Tan Sheet" Nov. 20, p. 5). Sandoz issued a press release Feb. 21 announcing that "for the first time, two well-controlled clinical studies have proven that an antihistamine significantly reduces cold symptoms." The release, handled by Publicis Public Relations, Dallas, also mentions the advisory committee recommendation, noting that "clemastine fumerate is the only 12-hour antihistamine proven cold-effective"...
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
