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On June 5, China Resources Shuanghe issued an announcement that its wholly-owned subsidiary, Shuanghe Limin Irbesartan Dispersible Tablets, passed the approval of the Quality and Efficacy Consistency Evaluation of Generic Drugs by the State Food and Drug Administration on May 24, and obtained the "Supplementary Drug Application" Approval Notice" (Notice Number: 2021B01604), which is the first dispersible tablet approved
.
The drug is mainly used for the treatment of essential hypertension and type 2 diabetic nephropathy combined with hypertension
.
Irbesartan tablets, developed by the French company Sanofi, were approved by the European Medicines Agency (EMA) on August 27, 1997, and were approved by the U.
S.
Food and Drug Administration (FDA) on September 30, 1997.
It was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) on April 16, 2008
.
The trade names of Irbesartan tablets produced by Sanofi in Europe and the United States are APROVEL and AVAPRO, respectively
The dosage form produced by Shuanghe Limin is irbesartan dispersible tablets
.
According to data from Minai.
This review will benefit the future market sales of the drug and accumulate valuable experience for the follow-up evaluation of the consistency of generic drugs for other products, which will have a positive impact on the company's business performance
.
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