The most complete! Analysis of 137 new drugs approved by CDER in 2020

In 2020, the FDA's Center for Drug Evaluation and Research (CDER) first approved 137 NDA and BLA applications, of which 22 were BLA applications, and the classification of NDA applications is listed below.
45 of the 111 newly approved NDA applications were designated for orphan drugs (40.5 per cent) and 60 were approved by 505 (b) (2) (54 per cent), it can be seen that orphan drugs and 505 (b) (2) declaration routes in 2020 are still preferred declaration strategies for pharmaceutical companies.
The advantages of the 505 declaration pathway can be seen in the public article: in the first half of 2020, FDA approved 505 (b) (2) new drug analysis, and the advantages of orphan drugs can be seen in the public article: orphan drug 7 years market exclusive rights loophole is about to be filled? The seven-year market exclusive right mentioned, a 50% reduction in qualified clinical research fees (tax credits), and accelerated review of preferential policies such as listing.
The advantages of short development cycles, low research and development costs, high pricing and high profitability have made drug companies eager to declare orphan drugs, and examples of orphan drugs becoming a bombshell (with annual sales of more than $1 billion) abound, as well as Novarma's Gretini in "I Am not a Drug God" (Imadini). It's an orphan drug with annual sales of more than $4.5 billion between 2011 and 2015; Merck's Keytruda, which earned more than $11.1 billion in sales in 2019, was approved for its first approved adaptation, melanoma, with accelerated approval for orphan drug designation.
11 of the new drugs approved in 2020 received provisional approval, which ultimately included Thessano's HIV compounding agents (Dotiravir, Ramifedin, and Fumarate Novovir), which were granted by the FDA in September-October 2020.
According to the author's statistics, this year there are three drugs each received a rare pediatric disease priority review, namely Koselugo: kinase inhibitors, the treatment of children 2 years of age and older I. neurofibromatosis (NF1).
Zokinvy: A French-based metastase inhibitor for patients with early aging syndrome with a surface area of 0.39 m2 and above for 12 months and older.
Oxlumo: Primary high oxalic acid urine type 1 (PH1) for the treatment of children and adults, reducing urinary oxalic acid levels.
according to the FDA's newly released 2020 Summary Page, 53 innovative drugs (40 NDAs plus 13 BAs) approved by the FDA in 2020 are second only to 2018 (see figure below).
by comparison, 40 innovative drug NDA, the type of Type 1 new molecular entity in the NDA classification above, and the only Type 1 drug not included in the NDA NDA was Artesunate (Artesunate) of La Jolla Pharma, which was approved on 29 May, because the same drug from Amivas was approved on 26 May and granted an orphan drug franchise (FD and Act, 21 U.S.C .
la Jolla Pharma products are provisionally approved and may not be finally approved for listing under section 505 of the FD and C Act unless the expiration of the term.
53 innovative drugs approved by the FDA in 2010-2020 are outlined in the table below.