"Tablets that take longer than 30 seconds to disintegrate or are dosed with liquids may be more appropriately considered to be chewable or oral tablets," FDA says in a draft guidance on orally disintegrating tablets scheduled for publication in the Federal Register April 9. Additional parameters for consideration include tablet size, weight and component solubility, the agency adds. Because performance characteristics distinguish these products as separate dosage forms, matching the characteristics is an important requirement for ODT labeling, FDA notes. A wide variation in product characteristics in the first disintegrating tablets to reach the market prompted the agency to develop guidance for the category. Excedrin QuickTabs and Claritin Redi-Tabs are among the offerings in the OTC market...
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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.’
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
