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Recently, the official website of
N MPA showed that Sichuan Haisco Pharmaceutical’s application for the listing of the 3 generic drug avanafil tablets (acceptance number: CYHS1900563/4) has entered the "under review" status and will soon be approved, becoming the first imitation and the first in China.
Avanafil tablets approved for marketing .
Avanafil (trade name: Stendra)
from the official website
of NMPA is an oral fast-acting and highly selective phosphodiesterase-5 (PDE-5) inhibitor for the treatment of erectile dysfunction (ED) .
The drug was originally developed by Vivus Corporation of the United States authorized by Tanabe Mitsubishi Pharmaceutical Co.
, Ltd.
, and was approved by the U.
S.
FDA for listing in the U.
S.
on April 27, 2012
.
Currently in the United States, Germany, France and other countries on the market, no domestic production and imports
.
In a clinical trial, 80 patients with erectile dysfunction took avanafil (50, 100, 200 mg) and sildenafil (50 mg) placebo respectively.
The results showed that the avanafil group and sildenafil The penile hardness of the subjects in the group was similarly improved, but after oral administration of avanafil, the peak effect was reached faster than that of sildenafil
.
Clinical results show that avanafil can be used to treat erectile dysfunction safely and effectively, and it is effective for both type 1 and type 2 diabetic patients with erectile dysfunction and those with erectile dysfunction who have undergone prostatectomy
.
According to research statistics, the prevalence of ED in men over 40 years old at home and abroad is as high as 40%
.
The I Nsight database shows that the domestic market has been approved PDE-5 targets ED drugs are mainly three kinds , namely tadalafil, sildenafil and vardenafil, which, in order tadalafil won The largest number of enterprises, a total of 14 companies, belong to the second batch of collectively harvested varieties; followed by sildenafil , a total of 11 companies have been approved, belonging to the third batch of collectively harvested varieties; Vardenafil currently only The first copy of the Colum family was approved
.
From the Insight database (http://db.
dxy.
cn/v5/home/) The Insight database shows that in terms of avanafil, apart from Haisco, only the Shanghai Huilun company reported production , and the reporting time was only slower than Haisco 1 month, currently in the first round of supplementary information tasks
.
In addition, Kunming Jida Pharmaceuticals is in the BE trial, the original Menarini Group and Ruiyang Pharmaceuticals, another generic drug company, are in phase I clinical trials, and 14 other companies have been approved for clinical trials
.
N MPA showed that Sichuan Haisco Pharmaceutical’s application for the listing of the 3 generic drug avanafil tablets (acceptance number: CYHS1900563/4) has entered the "under review" status and will soon be approved, becoming the first imitation and the first in China.
Avanafil tablets approved for marketing .
Avanafil (trade name: Stendra)
from the official website
of NMPA is an oral fast-acting and highly selective phosphodiesterase-5 (PDE-5) inhibitor for the treatment of erectile dysfunction (ED) .
The drug was originally developed by Vivus Corporation of the United States authorized by Tanabe Mitsubishi Pharmaceutical Co.
, Ltd.
, and was approved by the U.
S.
FDA for listing in the U.
S.
on April 27, 2012
.
Currently in the United States, Germany, France and other countries on the market, no domestic production and imports
.
In a clinical trial, 80 patients with erectile dysfunction took avanafil (50, 100, 200 mg) and sildenafil (50 mg) placebo respectively.
The results showed that the avanafil group and sildenafil The penile hardness of the subjects in the group was similarly improved, but after oral administration of avanafil, the peak effect was reached faster than that of sildenafil
.
Clinical results show that avanafil can be used to treat erectile dysfunction safely and effectively, and it is effective for both type 1 and type 2 diabetic patients with erectile dysfunction and those with erectile dysfunction who have undergone prostatectomy
.
According to research statistics, the prevalence of ED in men over 40 years old at home and abroad is as high as 40%
.
The I Nsight database shows that the domestic market has been approved PDE-5 targets ED drugs are mainly three kinds , namely tadalafil, sildenafil and vardenafil, which, in order tadalafil won The largest number of enterprises, a total of 14 companies, belong to the second batch of collectively harvested varieties; followed by sildenafil , a total of 11 companies have been approved, belonging to the third batch of collectively harvested varieties; Vardenafil currently only The first copy of the Colum family was approved
.
From the Insight database (http://db.
dxy.
cn/v5/home/) The Insight database shows that in terms of avanafil, apart from Haisco, only the Shanghai Huilun company reported production , and the reporting time was only slower than Haisco 1 month, currently in the first round of supplementary information tasks
.
In addition, Kunming Jida Pharmaceuticals is in the BE trial, the original Menarini Group and Ruiyang Pharmaceuticals, another generic drug company, are in phase I clinical trials, and 14 other companies have been approved for clinical trials
.
