The FDA has approved SkyePharma’s Foradil Cerihaler (formoterol fumarate inhalation powder) for the treatment of asthma. Foradil Cerihaler has been co-developed by SkyePharma and Novartis, and is a trademark of Novartis.
The FDA has approved EMD Pharmaceuticals’ Cyanokit (hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning. The approval, which is based on evidence of the drug's effectiveness when tested in animals, improves the nation's ability to respond to emergencies, including a potential attack by terrorists, the FDA said.
The FDA warned yesterday that two patients taking Rituxan died from the rare brain infection progressive multifocal leukoencephalopathy or PML. The patients who died were receiving the drug as an off-label treatment for lupus. Rituxan, sold by Genentech and Biogen Idec was approved nearly 10 years ago as a treatment for non-hodgkins lymphoma. Sales of Rituxan were at $1.8 billion for 2005.
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