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Lotus's ANDA of Calcium Acetate Capsule has been officially approved by the US FDA

27 June 2016

Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that its ANDA (“Abbreviated New Drug Application”) of Calcium Acetate Capsule 667mg for renal disease has been officially approved by US FDA. The Company will start the preparation for product commercialization in the US market accordingly.

Calcium Acetate Capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal diseases. Upon litigation settlement, Lotus received the approval earlier than expected. Lotus now is capable of offering a comprehensive portfolio in the US market. Additionally, this is the fourth US ANDA approval Lotus has received since the beginning of 2016, after the approvals of Paricalcitol, Temozolomide and Levetiracetam. It further solidifies the growth momentum for Lotus’ export business in 2016 and beyond.