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Generic Approvals Rebound as First Generics Don’t Keep Pace With 2016 or 2017

Posted 09 July 2018 | By Zachary Brennan 

Generic Approvals Rebound as First Generics Don’t Keep Pace With 2016 or 2017

A lull in generic drug approvals (partially due to a new requirement) in January and February has not stopped the number of approvals from continuing to rebound in April and May, according to the US Food and Drug Administration’s (FDA) latest monthly tallies of generic statistics.

And though the approvals in April and May are only matched by late 2017, the number of complete response letters has also increased to a high not seen since January. The number of discipline review letters has also increased from a low of 35 in January to a high of 224 just two months later and a near-high of 216 in May.
 
Month Generic Drug Approvals Complete Responses
October 2017 87 325
November 84 240
December 78 242
January 2018 25 307
February 32 184
March 57 158
April 66 142
May 67 185
 
First Generics

Meanwhile, the number of first generic approvals (meaning the first competitor for a brand name drug) has not kept pace with 2017 or 2016. As of the end of June, just 30 first generics have been approved, compared with a total of 80 in 2017 and 73 in 2016. But the decrease may be due to patent litigation or other issues that are not a sign of the generics industry failing to file new abbreviated new drug applications for first generics.

Teva announced Monday that it launched the first generic version of Uceris (budesonide). Other recent notable first generic approvals were for Suboxone (three from Mylan and Dr. Reddy’s) and Teva’s approval for a Cialis (tadalafil) competitor in May.
 

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