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  • First Samsca generic submits approval application
  • by Lee, Tak-Sun | translator Byun Kyung A | Dec 19, 2019 06:34am
MFDS accepts application on Oct 31, likely to be Myung In Pharma
 ¡ã ¿ÀÃ÷Ä« <»ï½ºÄ«>
The first generic to follow Korea Otsuka Pharmaceutical¡¯s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS).

The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and developing the follow-on drug.

According to MFDS on Dec. 17, a tolvaptan-containing drug submitted an application for approval. The drug in 15 mg dose is administered once-daily to treat patients with hyponatremia.

As stated by the Drug Approval-Patent Linkage system, MFDS notified Otsuka, the patentee, about the submitted application.

Otsuka¡¯s Samsca is protected by a pate
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