Novartis Tavist NightTime Allergy provides "relief from sinus & nasal congestion, runny nose & sneezing" with an antihistamine "so you can rest," product labeling says. Line extension, which began hitting shelves in March, contains diphenhydramine 25 mg as an antihistamine, pseudoephedrine 60 mg as a nasal decongestant and is the only OTC positioned primarily for relief of nighttime allergy symptoms, Novartis says. Available in 24- and 48-count caplets for between $3.99 and $6.99, NightTime Allergy is the Tavist line's fourth offering. Product, which was originally named Tavist D/A, was slated to debut a year ago (1"The Tan Sheet" March 5, 2001, p. 5)...
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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.’
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.
