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The China National Pharmaceutical Administration's Center for Drug Evaluation (CDE) has recently announced that Sanofi (SNY.US) has received approval for its application to market oral suspension of clemastine fumarate. Clemastine fumarate is a second-generation antihistamine that has already been approved in China for the treatment of allergic rhinitis and chronic idiopathic urticaria. This application is for the oral suspension formulation. According to Sanofi's previous press release, clemastine fumarate is a second-generation antihistamine with the characteristics of rapid onset, 24-hour long-lasting, and no sedation, and low occupancy of brain receptors. It has a high affinity for H1 receptors, indicating good cardiac safety. Oral suspension is a more convenient treatment option for people with difficulty swallowing. Sanofi has developed various formulations such as capsules, tablets, and combined formulations for this product. In 2006, the company's pediatric oral suspension was approved for marketing in the United States.
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