The FDA Office of Generic Drugs recently published its 2018 Annual Report.  The report addresses: 

  • the agency’s publication of guidance, policies, and procedures;
  • product approvals and regulatory actions;
  • and an overview of actions taken during the first year of GDUFA II.

We will highlight some of the reported accomplishments and delve into others in more detail.  Table 1 on page 3 of the report describes the significant GDUFA II performance goals and commitments.

Approval Activities

In 2018, the FDA approved 1021 ANDAs with a record number in July when 96 final approvals were granted along with 30 tentative approvals and 357 complete responses issued.  Full approval was granted to 801 drugs while the remaining 211 received a tentative approval where final approval will be granted when patent and exclusivity issues have been successfully addressed.

Among the approvals were some for the first generic of the innovator drug.  FDA considers this to be a priority to ensure that a robust pipeline of generic drugs is available to the public.  FDA also implemented a pathway for approval of drugs for which there currently are no generics available.   Five drugs in this category were approved in 2018.  Implementation of this category represents the fulfillment of a pathway described in Section 803 of the FDA Reauthorization Act of 2017 (FDARA).

The overall quality of the ANDA submissions to FDA has improved with refuse-to-receive designation down to less than 7% compared to approximately 13% the year before.

Along with the 1,000-plus approvals of original ANDAs, FDA also approved, or tentatively approved, 894 prior-approval-supplements.  FDA also sent 2,648 Complete Response Letters (CRL). Personally, that seems like a very large number of CRLs, at more than twice the number of approvals, particularly because the only clinical data necessary, in general, are BA/BE studies rather than the usual raft of safety and efficacy investigational studies.  It would be interesting to have the FDA provide some additional granularity on the CRLs issued.

An area of particular challenge for generic drug makers and FDA alike are complex drugs including delayed and extended release dosage forms.  In this product category, the first approval for a generic epinephrine auto-injector was granted this year.


As mentioned above, complex drug development by generic drug firms and their review remain a challenge and an area of FDA focus.  The OGD has taken significant action in this area to support their development and assist manufacturers in bringing this important class of generic drugs to market.  Among the specific actions taken in this area:

  • 115 Product Specific Guidance for complex products have been issued to clarify the FDA’s expectations for this product class and support their development and approval.  This represents almost half of the new product-specific guidance (128) and revised product-specific guidance (117) issued in 2018.  
  • Adhesion properties and other performance expectations for transdermal delivery systems were the subject of the revised draft guidance and draft guidance, respectively that were published during the year.

Three important documents were published in support of the Drug Competition Action Plan to increase transparency in the submission and review practices for ANDAs, including:

In addition to these three, ten others were published in 2018 and are identified on page 21 in the Appendix to the Annual Report.  The Resource section on page 22 provides a valuable listing of resources available to the generic drug industry and those who want to know more about this product category.  A word of warning, many of the links within the document appear to have been impacted by FDA’s launch of their new website and instead of identifying the desired page, the dreaded ‘page not found’ message appears.

Regulatory Science

FDA’s regulatory science efforts seem heavily focused on the area of complex products, whether that is complex APIs or dosage forms, delivery routes, or combination products.  FDA published articles in these areas that should assist generic companies in developing products in these categories and increase the efficiency and consistency of FDA review. 


The annual report presents an interesting collection of activities focused on FDA’s efforts to increase the efficiency of generic drug development, quality of ANDA submissions, and streamline FDA’s review of this category of drugs.

Missing from this report is anything on enforcement metrics for these drugs.  For example, are generic drug manufacturers subject to a higher percentage of enforcement actions, including warning letters, import alerts, and recalls than innovative drug manufacturers?  The recalls of angiotensin II receptor blockers, the ‘sartans’, for nitrosamine contamination comes to mind.  These recalls are ongoing and have led to at least one warning letter.

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