Regulatory Focus™ > News Articles > 4 > US Generic Drug Approvals Tick Upward in March and April

US Generic Drug Approvals Tick Upward in March and April

Posted 18 April 2018 | By Zachary Brennan 

US Generic Drug Approvals Tick Upward in March and April

2018 kicked off on a low note for generic drug approvals, but according to the latest activities report, the US Food and Drug Administration (FDA) in March began inching back to its fiscal year highs for approvals.
 
The decline in abbreviated new drug application (ANDA) approvals seen in January and February was attributed, at least partially, to the implementation of a new 1 January deadline for companies tracking elemental impurities. But those issues seem to have abated. 
 
Month Generic Drug Approvals Complete Responses
October 2017 87 325
November 2017 84 240
December 2017 78 242
January 2018 25 307
February 2018 32 184
March 2018 57 158

Robert Pollock, a senior advisor at Lachman Consultants, told Focus that he thinks the recent trend shows that the elemental impurities issue “appears to be less of a problem. I was a bit concerned the first 7 days in April due to very low numbers of approvals but April now appears to be in line with March approvals or even may even exceed March if the daily numbers for April continue.”
 
In addition to the growth in approvals in March and April, complete responses (CRs) sent in March also continued to decline, with less than half the number of CRs sent in March when compared to October 2017.
 
The updated figures come as FDA has released new considerations for applicants deciding when to submit elemental impurity data: One for ANDA applicants with a goal date in February and when the elemental impurity issue is the only outstanding deficiency, and the other for applicants with official goal dates in several months.
 
"In general, FDA recommends that any applicant who has not fully addressed elemental impurities in their applications in their current form submit the information as soon as possible," the agency said.
 
Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe