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2015 505(b)(2) NDA Approvals

2015 was a big year for FDA, with 45 novel new therapies approved — much higher than 28, the average number approved in the past decade. Of the 45 approved in 2015, how many were approved through the 505(b)(2) pathway? And how does the number of approvals through 505(b)(2) compare with previous years? The results we’ve found from our proprietary database are informative.

Novel Drug Approvals (NMEs)

According to the FDA’s Center for Drug Evaluation (CDER) Novel Drugs 2015 Summary, 45 novel drugs were approved as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs) in 2015. Although applications for new approvals remained steady, CDER approved a higher than average number of novel drugs in 2015 (see our blog post here and the chart below for trends in NME approvals).

There are a few interesting statistics on these new drug approvals related to their potential positive impact on public health and quality medical care:

  • About 47% (21 out of 45) of the novel drugs approved in 2015 were for the treatment of orphan diseases (those diseases affecting less than 200,000 Americans)
  • A number of regulatory methods were used to expedite approval of novel drugs in 2015, including: Fast Track, Breakthrough, Priority Review, and Accelerated Approval pathways (see graphs below). In total, 27 (60%) of the novel drugs were designated in one or more of the expedited categories meant to speed drug development and/or application review processes.
CDER Novel Drugs 2015 Summary
*These pathways are not mutually exclusive, and many products are represented multiple times (eg, Alecensa® received both Breakthrough and Priority Review and Darzalex® had all 4).
Source: CDER Novel Drugs 2015 Summary
  • Two novel drugs were designated as Qualified Infectious Disease Products by the Generating Antibiotics Incentives Now Act (GAIN), which provides incentives to Sponsors bringing new antibiotics or antimicrobials to market.
  • 87% (39 of 45) of the novel drugs were approved during the first cycle of review

505(b)(2) Approvals

CDER does not track 505(b)(2) approvals as it does novel drug approvals. However, using Camargo’s proprietary 505(b)(2) database, we have performed a similar 2015 summary analysis of 505(b)(2) approvals in 2015. Approvals have remained strong, with 44* new approvals, up from 41 in 2014 (see graph below).

Number of 505(b)(2) approvals
Number of 505(b)(2) approvals each year from 2004 through 2015.
*Number confirmed to date; however, there are some approvals where the approval letter cites 505(b) only and review documents are not yet available
Source: Camargo proprietary database


The number of 505(b)(2)s and novel drugs approved in 2015 is similar (44 [identified to-date*] and 45, respectively).

Of the novel drug approvals, 4 were approved through the 505(b)(2) pathway.

Overlap of Drug Approvals (NMEs and 505(b)(2)s
Overlap of Drug Approvals (NMEs and 505(b)(2)s

These 4 505(b)(2)s approved as NMEs include:

  • Cholbam (approved by Office of Drug Evaluation III)
    • Indicated for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and as an adjunct treatment for patients with peroxisomal disorders
    • Received priority review and orphan designation (with 7 years exclusivity) as well as a rare pediatric disease voucher (see Camargo blog post on the financial and regulatory benefits of the voucher program)
  • Xuriden (approved by the Division of Metabolism and Endocrinology)
    • Indicated for the treatment of hereditary orotic aciduria
    • Also received priority review, breakthrough designation, and orphan status and a rare pediatric disease voucher
  • Avycaz (approved by the Office of Antimicrobial Products)
    • Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a new beta-lactamase inhibitor. The inclusion of avibactam in the fixed-combination is why Avycaz is classified as a NME.
    • Indicated for the treatment of adults with complicated intra-abdominal infections used in combination with metronidazole and complicated urinary tract infections, including Pyelonephritis
    • Received Fast track designation and priority review
    • Avycaz is the 5th approved antibacterial product designated as a Qualified Infectious Disease Product (QIDP), a designation given to antibacterials (or antimicrobials) that treat serious or life-threatening infections under the GAIN title of the FDA Safety and Innovation Act (look out for an upcoming blog on the benefits of QIDP designation under GAIN, which include 5 additional years of additional exclusivity and the aforementioned priority review and eligibility for fast track designation)
  • Aristada (approved by the Division of Psychiatry Products)
    • An atypical antipsychotic indicated for the treatment of schizophrenia

Each NDA is assigned a chemical type, such as “New molecular entity” or “new dosage form” to characterize the newness of a drug. The top 3 categories (new manufacturer [41%], new dosage form [30%], and new combination [16%]) are similar to past years, with the number of NMEs increasing compared to last year (9% vs. 2.4%, or 4 vs. 1 NMEs approved); see Camargo’s blog post on 2014 approvals), debunking the myth that developers cannot use the 505(b)(2) regulatory pathway to obtain NME status and the associated exclusivity benefits.

505(b)(2)s by Chemical Type
Source: Camargo proprietary database

*This is the number that have been confirmed to date; however, there are some approvals where the approval letter cites 505(b) only and review documents are not yet available.