USA-based ViroPharma (Nasdaq: VPHM) said yesterday that the European Commission has granted a Centralized Pediatric Use Marketing Authorization (PUMA) for Buccolam (midazolam, oromucosal solution), for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years of age.
This action by the European Commission represents the first product approval through the centralized PUMA procedure since its inception. In connection with the approval of Buccolam, ViroPharma will make an additional payment of £10 million ($16.2 million) to the former owners of Auralis, which was acquired last year.
Provides “welcome” alternative to current therapy
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze