The distributor of a coffee product found to contain an analogue of the erectile dysfunction drug sildenafil receives an official FDA warning letter Aug. 23, following a consumer advisory and voluntary recall in June (1"The Tan Sheet" July 5, 2010, In Brief). INZ Distributors of Brooklyn, N.Y., sells an unapproved, misbranded new drug, the agency's New York District office says. Magic Power Coffee is an adulterated food, due to the presence of an ingredient not generally recognized as safe, and improperly labeled as a dietary supplement given its representation as a conventional food/beverage, FDA says. INZ faces product seizures and possible injunction if it fails to correct the violations within 15 days, according to the letter
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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.