Specialty Drug 2019 Prescription Drug User Fee Act (PDUFA) Schedule – FDA Calendar

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. These fees serve as a secondary source of funding for the FDA and serve to expedite the review process.  The FDA establishes specific performance goals regarding the timeframe for review of products.1  Although these timeframes are numerous for new drug products the review period can range from 6 to 10 months depending on the application’s priority of review.

This publication provides an overview of what to expect from the FDA in 2019 based on established PDUFA dates for identified specialty drugs.

(The 2018 publication on PDUFA dates can be accessed at:  https://rjhealth.com/2018/03/16/specialty-drug-2018-prescription-drug-user-fee-act-pdufa-schedule/ ).

Note: As of the publication of this article, the United States government is in a budgetary shutdown, which may impact the ability of the FDA to meet its PDUFA obligations, especially those that are set during this time-period.

As of the publication of this article, we identified 32 unique specialty products, representing 37 distinct PDUFA dates due to supplemental indications for 2019. During our research and at the time of publication we were not able to determine if there were products with an established PDUFA date beyond September 2019.  In 2019, the oncology class continues to represent a disproportionate share of the applications (49%) (Figure 1).

rj health pudfa blog 2019 graph figure one therapy count january to september cardiovascular hematological oncology central nervous system immuniology musculoskeletal genetic metabolic

Fifty seven percent of the drugs have a designation of a priority review, therapies that are considered to be a significant advance in the treatment of a specific condition, while the remainder are under standard review.2  Products that are designated with a priority PDUFA review have an established goal of review within 6 months of the filing date, while standard review has a goal of 10 months. Oncology and hematological disorders, and immunology reflect the top therapeutic classes that have greater than two products under review with the greatest proportion of priority designations (Figure 2).

rj health pdufa 2019 blog figure 2 graph number of therapeutic agents musculoskeletal oncology metabolic immunology hematological genetic central nervous system cardiovascular

During our review in 2018 we noted that the evaluation of the molecule type revealed a trend towards greater submissions for biologically based drugs, with monoclonal antibodies representing the greatest proportion of products.  But this trend appears to be changing in 2019, as there is a greater number of submissions for small molecule drugs, being primarily driven within the oncology class (Figure 3). This shift is in alignment with recent strategy changes by manufacturers to develop more drugs that are self-administered and covered under the pharmacy benefit.

rj health pdufa blog 2019 graph figure 3 number of therapeutic agents antibody fusion protein monoclonal antibody synthetic peptide fusion protein monoclonal antibody conjugated immunoglobulin gene therapy small molecule coagulation factor

Utilizing the route of administration as a proxy for the potential benefit of coverage we estimated that 57 percent of the products would most likely be covered under the pharmacy benefit, while the remaining 43 percent would receive coverage under the medical benefit (Figure 4). Similar to our previous comment, these percentages are contrary to what we have found in previous years where we estimated that medically covered drugs would dominate the specialty pipeline. Again, suggesting a change in strategy towards greater self-administration of drugs and pharmacy benefit coverage.

rj health pdufa 2019 blog figure 4 route of administration of 2019 products intravenous oral parenteral subcutaneous

Of the applications submitted for review, 38 percent are for a new drug application (NDA or BLA), 57 percent were for currently approved drugs under review for supplemental indications (sNDA or sBLA), and biosimilars represented 5 percent (Figure 5).

rj health pdufa 2019 blog figure 5 drug application type by month in 2019 biosimilar new drug supplemental

Table 1 lists the specialty products with PDUFA dates in 2019 broken out by new, supplemental, and biosimilar drug applications.  Out of the 37 drugs, four with a PDUFA date in 2019 were approved at the end of 2018. Finally, sacituzumab received a complete response letter on January 17.

Table 1 – Specialty drugs with an established PDUFA date sorted by date3

Drug Name Company Name Approval Date Therapy Area Indication PDUFA Date
New Drug Applications


Amgen Musculoskeletal Disorders Osteoporosis January 16, 2019

(sacituzumab govitecan)

Immunomedics Oncology Metastatic Breast Cancer January 18, 2019


Ablynx Hematological Disorders Thrombotic Thrombocytopenic Purpura February 6, 2019


Alexion Pharmaceuticals December 21, 2018 Hematological Disorders Paroxysmal Nocturnal Hemoglobinuria February 18, 2019


Stemline Therapeutics December 21, 2018 Oncology Lymphomas February 21, 2019

(Turoctocog alfa pegol )

Novo Nordisk Hematological Disorders Hemophilia A February 26, 2019

(siponimod fumarate)

Novartis Central Nervous System Secondary Progressive MS March 1, 2019


Sanofi Metabolic Disorders Type 1 Diabetes March 22, 2019

(Immune globulin (human))

ADMA Biologics Genetic Disorders Primary Immune Deficiency April 2, 2019


Karyopharm Therapeutics Oncology Refractory Multiple Myeloma April 6, 2019

(quizartinib dihydrochloride)

Daiichi Sankyo Oncology Refractory Acute Myeloid Leukemia May 25, 2019

(onasemnogene abeparvovec)

AveXis Central Nervous System Spinal Muscular Atrophy May 31, 2019

(tafamidis meglumine)

Pfizer Metabolic Disorders Amyloid Cardiomyopathy July 1, 2019

(afamelanotide acetate)

Clinuvel Pharmaceuticals Genetic Disorders Porphyria July 8, 2019
Supplemental Indication Applications


AbbVie November 21, 2018 Oncology Acute Myelocytic Leukemia January 1, 2019

(cabozantinib s-malate)

Exelixis January 15, 2019 Oncology Hepatocellular Carcinoma January 14, 2019


Merck Oncology Melanoma February 16, 2019
Opdivo + Yervoy

(ipilimumab + nivolumab)

Bristol-Myers Squibb Oncology Non-Small Cell Lung Cancer February 20, 2019

(tipiracil hydrochloride + trifluridine)

Taiho Oncology Oncology Gastric Cancer February 24, 2019


Incyte Immunology Acute Graft-versus-Host-Disease February 24, 2019


Sanofi and Regeneron Immunology Atopic dermatitis March 11, 2019


Genentech Oncology Metastatic Breast Cancer March 12, 2019


Genentech Oncology Small-Cell Lung Cancer March 18, 2019


AstraZeneca December 19, 2018 Oncology Epithelial Ovarian Cancer March 29, 2019


AstraZeneca December 19, 2018 Oncology Fallopian Tube Cancer March 29, 2019


AstraZeneca December 19, 2018 Oncology Peritoneal Cancer March 29, 2019


Merck Oncology Non-Small Cell Lung Cancer April 11, 2019

(ruxolitinib phosphate)

Incyte Immunology Graft Versus Host Disease April 24, 2019


Sanofi and Regeneron Cardiovascular Reducing risk of cardiovascular events April 28, 2019


Sanofi and Regeneron Cardiovascular Hyperlipidemia April 29, 2019


Regeneron Pharmaceuticals Metabolic Disorders Non-Proliferative Diabetic Retinopathy May 13, 2019

(avatrombopag maleate)

Dova Pharmaceuticals Hematological Disorders Idiopathic Thrombocytopenic Purpura June 30, 2019

(tiopronin [INN])

Retrophin Genetic Disorders Cystinuria June 30, 2019
Otezla (apremilast) Celgene Cardiovascular Behcet Disease July 21, 2019
Tecentriq (atezolizumab) Genentech Oncology Non-Small Cell Lung Cancer September 2, 2019
Biosimilar Indication Applications
Trastuzumab Biosimilar Pfizer Oncology Metastatic Breast Cancer March 29, 2019
Rituximab Biosimilar Pfizer Oncology Follicular lymphoma Q3 2019

In the coming months we will be publishing information about the products covered in this article along with other relevant information to assist you in managing these products.  We will also update the PDUFA list and product evaluations as new information is released. If you have not seen our current pipeline evaluations, please go to the following link and register for notifications:  http://www2.rjhealthsystems.com/pipeline-review-access_drug-alerts


  1. PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2018 THROUGH 2022. Available at: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf . Last accessed: January 15, 2019.
  2. S. Food & Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. Available at: https://www.fda.gov/ForPatients/Approvals/Fast/default.htm

Last accessed: January 15, 2019.

  1. Pharma Intelligence Center, available at: https://pharma.globaldata.com/index.aspx

Last accessed: January 15, 2019.