FDA approves 108 first generics from 53 pharmaceutical companies in 2019
Release date: 2020-01-10 Views: 0
On January 8, 2020, the FDA's Center for Drug Evaluation and Research (CDER) summarized its first-time generic drug approved in 2019.
CDER approves a variety of new drug products every year. For generic drugs, the FDA provides safe, effective, high-quality scientific and regulatory advice to ensure that these universal alternatives are brought to market, meet needs, and provide patients with more affordable treatment options.
"First generic"-as the name suggests-this is the first FDA approval to allow manufacturers to sell generic drug products in the United States. The FDA considers first generic drugs important for public health and prioritizes review of these submissions.
In 2019, the FDA approved a total of 108 first generic drugs, involving 53 pharmaceutical companies.
The top six pharmaceutical companies with the most approved varieties are:
Teva Pharmaceuticals (Israel) 11
Mylan Pharmaceuticals (USA) 9
Amneal Pharmaceuticals (USA) 7
Par Pharmaceutical (United States) 6
Sun Pharmaceutical (India) 4
Novitium Pharma (United States) 4
Complete list of first generic drugs approved:
In terms of varieties, a total of 69 varieties were approved for the first imitation. The first five generic drugs with the most batches were:
Complete list of first generics approved:
- Basic introduction of Heilongjiang Hexiang Pharmaceutical Co., Ltd.
- How to contact Bermuda Medical (Shanghai) Regenerative Medicine Technology Co., Ltd.
- Shandong Dongfang Huiyi Health Industry Co., Ltd.
- Brief introduction of Zaozhuang Yinhai Pharmaceutical Co., Ltd.
- Contact information of Shandong Dongfang Huiyi Health Industry Co., Ltd.
- Introduction of Bermoudi (Shanghai) Regenerative Medicine Technology Co., Ltd.
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- 一批药停产（附名单） 3. Discontinuation of a batch of drugs (with list)
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- 2019年FDA共批准了53个制药公司的108个首仿药 6. In 2019, the FDA approved a total of 108 first generic drugs from 53 pharmaceutical companies
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