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In the past two days, CDE has successively included 7 varieties of 16 listing applications with acceptance numbers for priority revi.
From: CDE official website
National Drug Shortage Drug List Varieties
National Drug Shortage Drug List VarietiesDrug name: Neostigmine methyl sulfate injection;
Drug Name:Company name: Chengdu Yuandong Biopharmaceutical .
Company Name:
Proposed indications (or functional indications): (1) For myasthenia gravis, respiratory depression caused by curare (tubocurarine), postoperative or postpartum intestinal paralysis, gastrointestinal dysfunction, dysuria, e.
Proposed indications (or functional indications):
From: CDE official website
Neostigmine is an anticholinesterase drug developed by Shionogi .
Distribution of R&D Progress of Neostigmine Injection by Domestic Enterprises
From: Insight database (http://.
Drug name: methotrexate injection (pre-filled)
Drug Name:Company name: Shenzhen Kangzhe Biotechnology .
Company Name:
Intended Indication (or Functional Indication): For the treatment of severe, intractable, disabling psoriasis that is insensitive to conventional thera.
Proposed indications (or functional indications):
From: CDE official website
Methotrexate Injection (Prefilled) is a low-dose methotrexate (MTX) injection in a variety of strengt.
According to the Insight database, in addition to this indication, CMS is also exploring other indications for methotrexa.
Varieties of medicines for children
Varieties of medicines for childrenDrug name: digoxin injection;
Drug Name:Company name: Chengdu Better Pharmaceutical .
Company Name:
Proposed indications (or functional indications): 1) Adult heart failure: Digoxin injection is suitable for adults with mild to moderate heart failure, which can increase left ventricular ejection fraction, improve symptoms of heart failure, and improve exercise capaci.
Proposed indications (or functional indications):
From: CDE official website
Digoxin is a commonly used cardiac glycoside drug, which can slow down the heart rate, effectively improve the symptoms of heart failure and cardiac function, reduce the hospitalization rate and shorten the hospitalization time of patients with severe congestive heart failu.
Drug Name: Stiripentol Dry Suspension
Drug Name:Company name: Shijiazhuang Four Medicine .
Company Name:
Intended Indication (or Functional Indication): In combination with clobazam and valproate, clobazam and valproate during seizures in patients with severe myoclonic epilepsy in infants (SMEI, Dravet syndrome) Adjunctive treatment of refractory generalized tonic-clonic seizures that are not adequately controll.
Proposed indications (or functional indications):
From: CDE official website
Stiripentol received orphan drug designation in the European Union in 2001, followed by approval in the European Union in 2007 and in Japan and Canada in 2012 in combination with clobazam and valproate for severe myoclonus in infancy Adjuvant treatment of refractory generalized tonic-clonic seizures in patients with epilepsy (SMEI, Dravet syndrom.
According to the Insight database, there are currently 3 domestic companies developing tipentanol suspensions, namely Shijiazhuang .
Domestic layout of tiamyl alcohol enterprises
From: Insight database (http://.
d.
cn/v5/home/)
Drug Name: Clobazam Tablets
Drug Name: Company name: Yichang Renfu Pharmaceutical .
, L.
;
Intended Indication (or Functional Indication): Combination therapy for seizures in patients with Lennox-Gastaut syndrome (LGS) 2 years of age and old.
From: CDE official website
Clobazam is a rare disease drug for children with refractory epilep.
It was first approved for marketing in Australia in February 1970, and has been approved for marketing in more than 100 countries and regio.
As a new type of adjuvant therapy for LGS, compared with traditional 1,4-benzodiazepines, it has the characteristics of definite curative effect, high safety and good tolerability, and will become a new drug for doctors to treat patients with LGS including L.
A new option for intractable epilep.
According to the Insight database, there is currently no such active ingredient approved for listing in China, and this application is the first in Chi.
In addition to Yichang Renfu Pharmaceutical, Jinan Kehui Pharmaceutical Technology is developing the drug, which was approved for clinical use for the first time in March 201
The current situation of domestic enterprises' layout of clobazam
From: Insight database (http://.
d.
cn/v5/home/)
Drug name: Kaglutamic acid dispersible tablets
Drug Name: Company name: Ruikangdi (Beijing) Pharmaceutical .
, L.
Proposed indications (or functional indications): This product is used to treat hyperammonemia caused by primary deficiency of N-acetylglutamate synthase (NAGS) in adults and children, and isovaleric acidemia (IVA) ), hyperammonemia caused by methylmalonic acidemia (MMA), hyperammonemia caused by propionic acidemia (P.
From: CDE official website
Kaglutamate is a rare disease drug, initially approved overseas for hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency, and the first FDA-approved drug for the treatment of patients with .
or drugs for acute hyperammonemia caused by M.
According to the Insight database, Kaglutamic acid has not been approved for listing in China at present, and this application is planned to be included in the priority review, which will also accelerate the domestic listing process of Kaglutamic ac.
Domestic enterprise Kaglutamic acid research project
From: Insight database (http://.
d.
cn/v5/home/)
Clinically urgently needed varieties
Clinically urgently needed varietiesDrug Name: Sodium Thiosulfate Injection
Drug Name: Company name: Sichuan Huiyu Pharmaceutical .
, L.
Proposed indications (or functional indications): This product is mainly used for cyanide poisoning, and can also be used for arsenic, mercury, lead, bismuth, iodine and other poisoni.
From: CDE official website
Sodium thiosulfate injection is a product on the national shortage li.
According to the Insight database, only 5 domestic companies are currently developing sodium thiosulfate injection (including sodium thiosulfate injection and sodium thiosulfate for injectio.
4 companies have been approv.
Layout of domestic enterprises of sodium thiosulfate
From: Insight database (http://.
d.
cn/v5/home/)
