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Lotus's ANDA of Temozolomde capsules has been officially approved by the US FDA

28 April 2016

Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that its ANDA (“Abbreviated New Drug Application”) of Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg, and 250mg for brain cancer has been officially approved by US FDA. The Company will start the preparation for product launch in the US market accordingly.

Temozolomide Capsules is an oral cytotoxic drug for brain cancer, which is a high barrier product due to the dosage form requirements and requires dedicated production facilities with strict standards for manufacturing. Lotus has the capability of manufacturing the oral cytotoxic products for the US market by itself backed by its superior production facilities in Nantou Taiwan which successfully passed its third FDA inspection earlier this year. Temozolomide Capsules is Lotus’ first cancer drug approved by US FDA and its comprehensive product offering with all dosage 5mg, 20mg, 100mg, 140mg, 180mg, and 250mg creates a competitive edge for better market awareness in the US. Lotus has launched Temozolomide Capsules in Taiwan for many years and also got the approval for EU markets last year.

For US market, Lotus has launched its Mefenamic Acid Capsule 250mg in 2014 and Levonorgestrel Tablet 1.5mg in 2015. In addition to the approved ANDAs of Paricalcitol in Feb’16 and Temozolomide in Apr’16, Lotus has 5 more ANDA filings submitted while waiting for US FDA approvals in pipeline.