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July Marks All-Time High in FDA Generic Drug Approvals

Posted 09 August 2018 | By Zachary Brennan 

July Marks All-Time High in FDA Generic Drug Approvals

The US Food and Drug Administration (FDA) approved or tentatively approved more generic drugs in July than in any other month ever before.

The highlight for FDA’s Center for Drug Evaluation and Research followed a steep decline in approvals from earlier in 2018. With the approvals in July also came an annual high in complete responses issued.

Here’s a look at the data:
 
Month Generic Drug Approvals
(tentative approvals)
Complete Responses
January 2018 25 (6) 307
February 32 (5) 184
March 57 (11) 158
April 66 (16) 142
May 67 (19) 185
June 74 (18) 217
July 96 (30) 357

Categories: Regulatory News

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