New developments in drug launches! 2 exclusive varieties and 8 MAH approval documents were approved

In November, 21 new approvals were issued by SFDA; Approval documents for 14 new varieties in November; In November, 20 domestic drug approvals and one import approval were added According to the latest statistics of pharmaceutical intelligence data Enterprise Edition, 21 new approvals will be issued in November 2019 Figure I new approvals from September to November 2019 In November, 20 new approvals were issued for domestic drugs and one for imported drugs See the detailed analysis of new approvals below In November, the drug administration added 20 chemical drug approvals and one biological product approval Figure 2 drug types of drug administration from September to November 2019 In November, FDA added 8 injections, 10 tablets, 1 capsule, 1 inhalation preparation and 1 oral solution Figure 3: situation of various dosage forms of drug administration from September to November 2019 Among the new approvals in November, 9 belong to class B drugs in 2019 new national medical insurance catalog, and 3 belong to class a drugs in 2019 new national medical insurance catalog Figure 4 medical insurance categories of SFDA from September to November 2019 In September, the registered address of new approved production enterprises was the most in Hainan, with 5 Figure 5 number of approvals in each province in November 2019 In November, the new approval documents for the exclusive variety of glaxooperations ukltd (trading as glaxowellcomeoperations) of flutemavir inhalation powder mist (the exclusive variety also represents the exclusive variety of the same product specification) and Shanghai Green Valley Pharmaceutical Co., Ltd of ganlute sodium capsule were issued The listing license holder of ganlute sodium capsule is also Shanghai Green Valley Pharmaceutical Co., Ltd Flutamivir inhalation powder mist is suitable for the treatment of COPD in stable stage It contains inhaled glucocorticoid (ICS), long-acting anticholinergic drug (http://www.chemdrug.com/) (Lama) and long-acting β 2 receptor agonist (Laba) It is administered once a day through the dry powder inhalation device of elipta ®, a unique GSK device Ganlute sodium capsule is used for mild to moderate Alzheimer's disease to improve the cognitive function of patients Table I newly approved drugs in November 2019