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FDA approves record breaking 971 generic drugs in 2018

Published on 10/01/19 at 10:26am

The FDA approved a record 971 generic drugs in the 2018 fiscal year, giving the go-ahead to 110 generics in October alone, it has emerged.

The year saw an improvement on the previous record of 937 generics approvals set in 2017. The cost saving medicines were said to have saved consumers as much as $26 billion between January 2017 and July 2018.

As said by FDA commissioner Scott Gottlieb “Over the past two consecutive years, the agency approved record numbers of generic drugs. Now we’re beginning the new fiscal year by breaking another record, this time with the highest number of approved or tentatively approved generics ever in a month.

Through our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled.”

Louis Goss

Comments

How many are realy going to be commercial? If a drug ANDA is granted to multiple firms why should it be considered a NEW generic drug? Has any one done a tally of nay sorts or folks just publishing what is fed to them. I can bet a cup of coffee to these reporters who just publish things without thinking. That is how PRESS gets a BAD NAME and RAP.   

 

Based on FDA site [https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/] 

ONLY 70 First Generic Drug Approvals happened in 2018.

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