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Lotus Announces MFDS Approval for GRALISE® SR, Once-Daily Tablets for Post-Herpetic Neuralgia

27 March 2023

Taipei, Taiwan, 27 March 2023 -- Lotus Pharmaceutical, a multinational pharmaceutical company (1795:TT), has announced the approval of GRALISE®, a once-daily Gabapentin extended-release tablet, by the Ministry of Food and Drug Safety of Korea (MFDS). This marks the first sustained release formulation of Gabapentin approved in Korea for the treatment of Post-Herpetic Neuralgia (PHN).  GRALISE® utilizes a novel formulation to optimize drug delivery, enabling around-the-clock management of PHN with a single daily dose. The treatment offers enhanced convenience to patients compared to conventional immediate-release forms of Gabapentin.  PHN is a chronic and painful condition that can occur following shingles, a common viral infection.

Petar Vazharov, Lotus' Chief Executive Officer, expressed excitement for the approval of GRALISE®, stating: "We are thrilled to announce the approval of Gralise in Korea. With this approval, we have added another branded product to our strong neurology portfolio. This will further accelerate our growth in the region and more importantly, it highlights our ability to bring differentiated, novel treatments to the market."

According to IQVIA data, the overall market size of Gabapentin in Korea in 2022 was approximately USD 40 million.