Lotus Obtains Tentative Approval for Nintedanib ANDA from the US FDA

Lotus Pharmaceutical (Taiwan TWSE ticker: 1795) has announced 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.

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.

Petar Vazharov, Chief Executive Officer of Lotus

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

For further information visit Lotus' website.