- Methotrexate tablets is Lotus’ first oncology product approved by the US FDA since Lotus partnered with Alvogen in 2014. The product will be manufactured Lotus’ export-oriented facility in Nantou and will be distributed by Alvogen US in the US.
- Lotus is one of the few companies in Taiwan that is capable of exporting its in-house developed oncology products worldwide, including to the US - world’s largest pharmaceutical market.
Lotus Pharmaceutical Co., Ltd. (“Lotus” or “the Company”, Taiwan TWSE ticker: 1795) today announced that its ANDA for Methotrexate Tablets USP, 2.5 mg (equivalent to Dava Pharmaceuticals’ Rheumatrex ®) has been approved by the US FDA. The Company will start the preparation for launch in the US market accordingly. Methotrexate Tablets is indicated for the treatment of several cancer indications. The drug is also indicated for the treatment of psoriasis, polyarticular juvenile idiopathic arthritis and rheumatoid arthritis. According to IQVIA data, the total sales of Methotrexate Tablets in the US were approximately US$80 million for the 12 months ended December 31, 2020. Petar Vazharov, Chief Executive Officer of Lotus, commented: