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Lotus Obtains Tentative Approval for Nintedanib ANDA from the US FDA

16 January 2023

Taipei, Taiwan, 16 January 2023 -- Lotus Pharmaceutical (“Lotus” or “the Company,” Taiwan TWSE ticker: 1795), a multinational pharmaceutical company, announced today that the US Food and Drug Administration (US FDA) has granted a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, the generic version of Boehringer Ingelheim’s OFEV®. Lotus expects to launch the generic Nintedanib Capsules at the earliest available opportunity.

Petar Vazharov, Chief Executive Officer of Lotus, said: “We are excited to share that Lotus has received tentative approval from the US FDA for its ANDA for Nintedanib Capsules, which has enhanced our portfolio on lung cancer. After the successful launch of Lenalidomide Capsules in the US market in 2022, we are looking for more opportunities and reinforcing our competitiveness in the US.

The tentative approval of Nintedanib Capsules by the US FDA represents that we have the capability to be more advanced in the oral oncology market and provide more affordable pharmaceuticals for cancer patients around the world.”

According to IQVIA data, the total sales of OFEV® in the US were approximately US$1.8bn for the 12 months that ended December 31, 2021.