Four-count sample size units of Zantac 75 (ranitidine 75 mg) had an improper seal in their blister packaging, resulting in discoloration of the tablets from exposure to humidity, Warner-Lambert says. The firm-initiated recall involves just one lot shipped nationwide; close to 11,000 cases of the product were distributed (1see Recalls & Court Actions, p. 7)
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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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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.