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LOTUS RECEIVED TENTATIVE APPROVAL FOR ITS ANDA FOR LENALIDOMIDE FROM US FDA

Lotus Pharmaceutical Co., Ltd. (“Lotus” or “the Company”, Taiwan TWSE ticker: 1795) today announced that the Company received tentative approval for its ANDA (“Abbreviated New Drug Application”) for Lenalidomide Capsules (generic version of REVLIMID®) 2.5mg, 5mg, 10mg, 15mg, 20mg, and 25mg from US FDA. The Company expects to launch the product as per its settlement agreement with the originator in the US beginning on a confidential date that is some time after March 2022.

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