Sanofi (SNY.US) new antiallergy drug formulation submitted for market approval in China

The latest announcement on the official website of the Center for Drug Evaluation of the China National Medical Products Administration (CDE) shows that the application for the market approval of Sanofi's oral suspension of fexofenadine hydrochloride has been accepted. Public information indicates that fexofenadine hydrochloride is a second-generation antihistamine. Previously, fexofenadine tablets have been approved in China for the treatment of allergic rhinitis and chronic idiopathic urticaria. The current application is for the oral suspension formulation. According to a previous press release from Sanofi, fexofenadine hydrochloride is a second-generation antihistamine with characteristics such as fast onset, 24-hour duration, non-sedating effects, and low brain receptor occupancy. It has a high affinity for the H1 receptor, indicating good cardiac safety. Public information shows that oral suspension formulations may provide a more convenient treatment option for individuals with swallowing difficulties compared to tablet formulations. Sanofi has already developed various formulations such as capsules, tablets, and compound preparations for this product. In 2006, the pediatric oral suspension of this product was approved and launched in the United States.