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2017 505(b)(2) NDA Approvals Increase Dramatically and Review Times Decrease

40% Increase in 2017 505(b)(2) Approvals over 2016

The number of 2017 NDA approvals that used the 505(b)(2) regulatory pathway rose dramatically from 45 approvals in each of the last two years to an all-time high of 63 (Figure 1). The median review time for these 63 approvals was 10.0 months which is shorter than the median of 12.5 months for approvals from 2012-2016. Four 505(b)(2) NDAs (all designated priority review) had review times of 6 months or less and 14 had review times greater than 13 months. In all, there were 13 priority review products and 16 orphan designated products.

Figure 1: 505(b)(2) NDA Approvals (2003 - 2017)

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

Source: Camargo’s proprietary database

The top categories for 2017 505(b)(2)s are similar to previous years (2015 and 2016): new formulation or manufacturer (Type 5; 46%), new dosage form (Type 3; 20%), and new combination (Type 4; 12%).

Figure 2: Type of 505(b)(2)s Approved in 2017

Figure 2: Type of 505(b)(2)s Approved in 2017

Source: Camargo proprietary database

Two products that were previously marketed without an approved NDA (so-called DESI drugs, Type 7) were approved via the 505(b)(2) pathway in 2017. One of these, Ascor (ascorbic acid injection), was granted orphan drug designation for the treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient, or contraindicated (link here).

5 NMEs approved in 2017

Of the 505(b)(2) approvals in 2017, the following 5 (8%) were NMEs.

Benznidazole (benzidazole oral tablet)

  • Approved by the Division of Anti-Infective Products for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi, in pediatric patients 2 to 12 years of age.
  • Granted priority review and orphan drug designation.
  • Vabomere (meropenem and vaborbactam powder for intravenous infusion)
    • Approved by the Office of Antimicrobial Products for the treatment of patients 18 years of age and older with complicated Urinary Tract Infections, including pyelonephritis.
    • Granted priority review.
    • This is a combination product containing the active ingredients meropenem and vaborbactam. Vaborbactam is the NME in this product, while meropenem was approved in the US in 1996 for the treatment of complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections, and treatment of meningitis in pediatric patients.
  • Emflaza (deflazacort oral tablet and oral suspension; separate NDAs)
    • Approved by the Division of Neurology Products for the treatment of Duchenne Muscular Dystrophy in patients 5 years of age and older.
    • Granted priority review and orphan drug designation.
  • Austedo (deutetrabenazine oral tablet)
    • Approved by the Division of Neurology Products for the treatment of chorea associated with Huntington’s Disease. A second 505(b)(2) NDA for Austedo was approved later in the year for the treatment of tardive dyskinesia.
    • Granted orphan drug designation for the Huntington’s Disease indication. The NDA for the tardive dyskinesia indication was granted priority review.

Camargo is the only consulting company in the world specializing in 505(b)(2) strategy and development, and worked on more than 20% of the 505(b)(2) NDAs approved in 2017. To learn more about ways Camargo can help you optimize your development program for the 505(b)(2) pathway, contact us.


Wen-Yee Choi, PhD, Scientific and Regulatory Manager, Camargo Pharmaceutical Services

Angela Drew, PhD, Product Ideation Consultant, Camargo Pharmaceutical Services