Generic Drug Approvals Stall in January as Elemental Impurity Questions Linger

Regulatory NewsRegulatory News | 07 February 2018 |  By 

The US Food and Drug Administration (FDA) approved generic drugs at record-high levels in 2017, though a new deadline related to elemental impurities has put a dent in that progress, at least preliminarily in January, according to the most recent generic drug activities report update.

In January, FDA says it has approved just 25 abbreviated new drug applications (ANDAs). And though that number could still be corrected, it is a far cry from the 87 ANDA approvals in October 2017, 84 ANDA approvals in November 2017 and 78 approvals in December 2017.

Questions were raised on this expected decline in ANDA approvals in January and the effect of a 1 January 2018 USP deadline on controlling elemental impurities in drug products, though drugmakers had known about that deadline for years.

FDA Commissioner Scott Gottlieb said on Twitter that January "had fewer generic approvals as companies work to implement new guidelines to protect patients from impurities like arsenic & lead in drugs. This is a temporary falloff in approvals. We should make up for the 1 month shortfall as the year advances."


The updated figures come as FDA on Wednesday released new considerations for applicants deciding when to submit elemental impurity data. The document offers two examples: 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 says.

For those with goal dates this month, FDA says: "If the applicant chooses to not submit information to address the elemental impurity issue today, they would receive a CR [complete response] on or before the GDUFA goal date. This CR could potentially only contain this one deficiency.

"In this example, the applicant would still receive a minor amendment goal date of 3 months upon the FDA receiving their post-CR amendment," the agency adds. "However, if the applicant submits an amendment during the current clock, the goal date would be extended 3 months from the date of the amendment. If the amendment sufficiently addresses the elemental impurity issue, FDA would be able to take action faster than waiting for a CR response and may be able to approve the application."

However, if the official goal date is in April or later, FDA says the review of elemental impurity information "could be subsumed under the current review clock. If an applicant is anticipating a quality discipline review letter (DRL) in March for an application due in August 2018, submitting this information immediately may not be needed, as a request for this information will likely be listed as a deficiency. However, for applications with user fee goal dates from now until the March/April time frame, it is in the applicants’ best interest to submit the necessary information as soon as possible."

Considerations for applicants deciding when to submit elemental impurity data to FDA


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