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Lotus's ANDA for methotrexate tablets approved by the US FDA

24 April 2021
  • 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:

We are glad to announce Methotrexate ANDA approval, which is the first oral oncology product initiated as a development since Alvogen and Lotus joined forces in 2014.  We are confident, based on Lotus US pipe line, that more ANDA approvals for products with higher market potential will follow. Since the strategic alliance with Alvogen, Lotus have been making significant investments in development of  niche oral oncology portfolio and upgrade of the manufacturing facilities located in Nantou, Taiwan. It’s great to see that our efforts over the last 6 years have started to bring results. Lotus today is not only one of the few companies in Taiwan capable of developing and manufacturing in-house oral oncology products, but also a leader with export network of partners in more than 80 countries worldwide - including US, Japan, China, EU, Middle East, Latin America, Australia and South East Asia. Lotus journey since 2014 from single market company to global presence with focus on oral Oncology is progressing very well.

Petar Vazharov

Chief Executive Officer