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Lotus Receives Tentative Approval for Midostaurin ANDA from the US FDA

25 August 2022

Lotus Pharmaceutical (1795:TT), a multinational pharmaceutical company, announced today that the U.S. Food and Drug Administration (USFDA) has granted a tentative approval for the Company's Abbreviated New Drug Application (ANDA) for MidostaurinSoftgel Capsules, the generic version of Novartis Pharmaceuticals’ Rydapt®.  Lotus expects to launch the generic MidostaurinSoftgelCapsules subject to the final outcome of the patent challenge litigation in the US.

Petar Vazharov, Chief Executive Officer of Lotus, said:“We are excited to share thatLotus has received tentative approval from the US FDA for its ANDAforMidostaurin soft gelatin capsules, which is Lotus’ firstNCE-1 ANDA submission. Midostaurin is our third successful filing in the US after Methotrexate Tablets, which is already on the market and LenalidomideCapsules, which has received tentative approval from the US FDA.

The tentative approval of MidostaurinSoftgelCapsulesby the US FDArepresents another milestone for Lotus in our journey to become a global supplier of oral oncology products and provide more affordablepharmaceuticalsfor the cancer patients around the world.”

According to IQVIA data, the total sales of Rydapt®(midostaurin) in the US were approximately US$83 million for the 12 months ended December 31, 2021.Currently, there is no approved generic competition to Rydapt® in the US.