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 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
GDUFA I	0	0	0	0	0	0	0	0	0		0
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
Approved ANDA	31	6	10	10	3	36	0	31	29		156
Unapproved ANDA	23	3	9	20	10	19	9	32	14		139
Withdrawals (PAS)	9	2	3	4	11	8	4	7	11		59
Approvals	110	99	69	82	83	89	93	83	45	61	814
First-Cycle Approvals (included above)	24	11	10	17	12	11	10	10	8		113
Tentative Approvals	22	32	39	24	19	17	18	12	17	14	214
First-Cycle Tentative Approvals (included above)	5	6	2	4	2	2	2	1	2		26

Source: U.S. Food and Drug Administration