Approval Surge: Nearly 40 New Drug Variants, Indications, and First-in-Class Generics Cleared by NMPA

Sep 09, 2023 09:02 CST Updated 09:02

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NMPA Releases Drug Approval Certificate Delivery Information on September 8, 2023The batch includes 103 approved acceptance numbers, one of which is for consistency evaluation., which is:

Jilin Yizheng Pharmaceutical Group Co., Ltd., Magnesium Aluminum Carbonate Chewable Tablets

This time, another 52 marketing applications have been approved., including:

Renfu Puke Pharmaceutical (Wuhan)Dutasteride Soft Capsules; Jumpcan'sAtomoxetine Hydrochloride Oral Solution; YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU JOINT STOCK CO., LTDPosaconazole Injection; Yantai Luyin PharmaceuticalDuloxetine Hydrochloride Enteric-Coated Capsules; China Resources Double-Crane PharmaceuticalsApremilast Tablets; Guangdong Jincheng JinSu PharmaceuticalTerbutaline Sulfate Injection; Chengdu Shengdi PharmaceuticalDiquafosol Sodium Eye Dropsetc.

Among them,Luye PharmaGoserelin Microspheres for Injection(Product name: Batuowei®) New indication approved，Breast cancer patients who are premenopausal and perimenopausal women eligible for hormone therapy。

Qilu PharmaceuticalDolutegravir Sodium TabletsApproved for Marketing(First Domestic Generic)，For the treatment of adult and pediatric patients aged 12 years and older with human immunodeficiency virus (HIV) infection。

Grand Pharmaceutical (China)Carglumic Acid Dispersible TabletsApproved for Marketing(First domestic generic)，For the treatment of hyperammonemia in adult and pediatric patients caused by various factors。

In addition, submitted by Jieti Pharmaceutical Technology (Shanghai)TheMitotane TabletsApproved for marketing in China.According to the priority review public notice information,The indication approved this time for the drug is adrenocortical carcinoma (ACC).

Merck's PD-1 InhibitorPembrolizumab(Trade name: Keytruda®) has been approved for a new indication, for use in adult patients with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors.