The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) and the company anticipates an approval response from the SFDA in the second half of 2007.
Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and treatment of hives in patients with chronic idiopathic urticaria. According to China Biopharmaceuticals, Desloratadine will be part of a $1.5 billion allergy drug market in China that continues to grow at a rate of 15% per year.
“If we are granted production approval, CHBP will be one of only four pharmaceutical companies producing Desloratadine tablets in China through 2010,” said Lufan An, president of China Biopharmaceuticals.
In a separate release, China Biopharmaceuticals also said that it is has that received authorization from the SFDA to initiate clinical trials to evaluate the safety and efficacy of Sofalcone for the treatment of digestive ulcers.