Wednesday, April 8, 2020

Wednesday, April 8, 2020

FDA Update: generic drug approvals


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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.

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Generic Drug Program Activities as of Aug. 9

Generic Drug User Fee Amendments (GDUFA)October 2018November 2018December 2018January 2019February 2019March 2019April 2019May 2019June 2019July 2019Fiscal-Year 2019
Refuse to Receive (RTR) - Originals744166635

42
Standard - GDUFA II633144535

34
Priority - GDUFA II111022100

8
GDUFA I000000000

0
Acknowledgement - Original5490666986958210359

704
Refuse to Receive (RTR) - Prior Approval Supplement (PAS)001100000

2
Withdrawals (all original Abbreviated New Drug Applications (ANDAs)5491930135596343

295
Approved ANDA316101033603129

156
Unapproved ANDA233920101993214

139
Withdrawals (PAS)92341184711

59
Approvals110996982838993834561814
First-Cycle Approvals (included above)24111017121110108

113
Tentative Approvals22323924191718121714214
First-Cycle Tentative Approvals (included above)562422212

26
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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