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2018 505(B)(2) Approvals in Review: Another Year of Double-Digit Growth

For the second year in a row, 505(b)(2) FDA approvals grew at double-digit rates according to Camargo’s proprietary database.

The number of 505(b)(2) approvals increased 19% from 63 in 2017 to a record-breaking 75 in 2018.

*Number to date; however, review documents are not yet available to confirm the regulatory approval pathway of some approved NDAs.

Median Review Time is on the Rise

While there were more approvals with review times of 6 months or less, overall median review time increased to more than a year (13.1 months), up from 10 months in 2017:

2017 2018*
Median review time 10 13.1
6 months or less in review 4 6
13 months or more in review 14 37

*2018 data excludes 2 of the 75 approvals due to missing submission date information

Sharp Decrease in the Number of Therapies Granted Orphan Designation

Therapies granted priority review were comparable to the previous year; however, fewer than one third of the therapies were orphan-designated products:

2017 2018*
Priority review granted 13 12
Orphan designation granted 16 5

*2018 data excludes 2 of the 75 approvals due to missing submission date information

New Formulation or Manufacturer Continues to be the Most Common Classification Type

At the time of submission, each NDA is assigned an FDA Submission Classification Type. The top three—new formulation or manufacturer, new dosage form and new combination—remain the same for overall 505(b)(2) approvals, dating all the way back to 2004.

Three Percent of All Novel Therapies Approved in 2018 Were 505(b)(2) Approvals

According to the FDA’s 2018 New Drug Therapy Approvals report, 59 novel therapies—those never before approved or marketed in the United States—were approved in 2018. Of these, two were 505(b)(2) approvals:

  • Annovera (segesterone acetate and ethinyl estradiol) (The Population Council Inc), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy. Annovera is the first vaginal ring contraceptive that can be used for an entire year.
  • Aemcolo (rifamycin) (Cosmo Technologies), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. The FDA granted Aemcolo a Qualified Infectious Disease Product (QIDP) designation. As part of QIDP designation, the Aemcolo marketing application was granted Priority Review.

For drug development companies, another record-breaking year of 505(b)(2) approvals signals the continued importance of this pathway to connect patients with the therapies they need.

If you are developing a new or enhanced product, let’s connect and explore how Camargo can optimize your program.