Docosanol 10% cream NDA (20-941) deemed "approvable" by FDA in May 30 letter. Final approval is expected in the third quarter after minor labeling issues are worked out, Avanir President and CEO Gerald Yakatan, PhD, says during a June 1 conference call. A proposed Rx version of the cream initially was determined "not approvable" by FDA due to missing data from a European trial and labeling concerns. The cold sore product will be marketed by SmithKline Beecham under a licensing agreement with San Diego-based Avanir. The introduction of the docosanol cream, expected to occur roughly six months after labeling is approved, will give SB another avenue into the OTC market. So far, SB has been unsuccessful in its attempts to switch its Rx cold sore drug Denavir (penciclovir) to OTC status
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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.’
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.
