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  • Novartis filed a lawsuit for Galvus¡¯ salt-altering drug
  • by Lee, Tak-Sun | translator Choi HeeYoung | May 29, 2020 06:17am
Novartis reported that Hanmi violated the obligation to notify Vildagle when applying for permission
The MFDS does not have to oblige notice, so it is said that the permit is legal
It was confirmed that Novartis has filed a lawsuit against the MFDS regarding the approval process of 'Vildagle 50mg' (Vildagliptin HCl), a DPP-4 series diabetes treatment drug that was approved in January.

Unlike the Novartis¡¯ Galvus (Vildagliptin), Hanmi's Vildagle is a salt-altering drug with HCl. In addition, Vildagle's indication doesn¡¯t include co-administration with Sulfonylurea or Metformin or Thiazolidinedione monotherapy if blood sugar control is not available.

According to the industry on the 28th, Novartis recently filed a lawsuit against the MFDS for request for suspension of execution and cancellation of item permission, saying that Hanmi was granted permission in violation of the obligation to n
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