Falloff in FDA Generic Drug Approvals Continues Into February

Regulatory NewsRegulatory News | 07 March 2018 |  By 

January saw a steep decline in the number of FDA approvals for generic drug applications when compared to the three previous months and all of FY 2017, and that trend is continuing into February, according to the latest activities report.

The report shows that generic drug approvals totaled just 32 in February, which even when combined with January’s generic approvals, is still shy of the generics approved in each of the previous three months.

Though the silver lining to February’s tally may be the number of complete responses, which also fell significantly from each of the previous four months of this fiscal year, perhaps meaning there was a drop in abbreviated new drug applications (ANDAs).
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
The decline in approvals seen in January and February is being attributed at least partially to the implementation of a new 1 January deadline for companies tracking elemental impurities.

FDA told Focus in a statement: "Recent elemental impurities guidelines may be one factor impacting approval numbers. Any impact will depend on whether firms have been taking steps to implement the requirements to protect patients from the risks posed by elemental impurities. FDA’s actions are dependent on whether applications meet the standards for approval, and the agency recommends that any applicant who has not fully addressed applications submit updated information as soon as possible to ensure timely review.

"The ICH and USP expert panels included industry participants who had input when establishing an implementation date. The date that was established provided a substantial amount of time in order to ensure that firms could conduct assessments and take the steps necessary to implement the requirements. We published a webpage with more information describing our previous outreach to industry on this topic as well as information for companies to consider if they have not yet fully addressed elemental impurity information in their application," FDA added, noting that it continues to meet user fee performance goals for generic drugs.
"While we are never pleased to see low numbers of approvals, FDA will continue to work with firms to ensure their applications are complete and meet the appropriate standards so that we may continue to approve ANDAs in a timely manner to increase competition in the marketplace," the agency said.
The agency added in a document on considerations for ANDA sponsors: "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.”

Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance


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