The U.S. Food and Drug Administration periodically provides information on the pace of generic drug approvals through its website.
Generic drugs produce similar health benefits to their original brand-name counterparts, according to the FDA. Generics are usually approved through abbreviated new drug applications (ANDAs) and offer lower-cost alternatives to the brand-name originals.
Generic drug applications are less complex because they do not usually require data on animal and human clinical trials to establish safety, the FDA reports.
Generic Drug Program Activities as of Aug. 9
|Generic Drug User Fee Amendments (GDUFA)||October 2018||November 2018||December 2018||January 2019||February 2019||March 2019||April 2019||May 2019||June 2019||July 2019||Fiscal-Year 2019|
|Refuse to Receive (RTR) - Originals||7||4||4||1||6||6||6||3||5||42|
|Standard - GDUFA II||6||3||3||1||4||4||5||3||5||34|
|Priority - GDUFA II||1||1||1||0||2||2||1||0||0||8|
|Acknowledgement - Original||54||90||66||69||86||95||82||103||59||704|
|Refuse to Receive (RTR) - Prior Approval Supplement (PAS)||0||0||1||1||0||0||0||0||0||2|
|Withdrawals (all original Abbreviated New Drug Applications (ANDAs)||54||9||19||30||13||55||9||63||43||295|
|First-Cycle Approvals (included above)||24||11||10||17||12||11||10||10||8||113|
|First-Cycle Tentative Approvals (included above)||5||6||2||4||2||2||2||1||2||26|