RJ Health Monthly Specialty FDA Actions Newsletter – May 2018 – Volume 1 – Number 5

May 2018 Specialty Drug FDA Actions

In May there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were eight supplemental drug approvals. The FDA had assigned eight new products for review and assigned five potential specialty products with June 2018 PDUFA dates. Finally, the FDA shifted the PDUFA dates for two products to later this year.

Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated administration by a professional, distribution by a specialty pharmacy or submission and reimbursement under the medical claim or Medicare Part B.

New Specialty Drug Approvals – May 2018 FDA drug approvals

May 2018 New Specialty Supplemental Indication Updates – Approved updated supplemental indications on currently marketed drugs in the previous month

Specialty Drug FDA Actions – New and supplemental FDA filings in the previous month

1. Resubmission to FDA completed and is expected to have a determination within 6 months.

Looking Ahead – Anticipated specialty drug FDA actions for 2018 and other significant changes.

1. FDA extended review period from June 4, 2018 to September 4, 2018
2. Review delayed by FDA from June 16, 2018 to September 16, 2018.

Review the April specialty drug FDA actions newsletter here.

_ 

Terms & Abbreviations:

1. aNDA: Abbreviated New Drug Application
2. BLA: Biologics License Application
3. FDA: Food and Drug Administration
4. NDA: New Drug Application
5. sBLA: supplemental Biologics License Application
6. sNDA: supplemental New Drug Application
7. PDUFA: Prescription Drug User Fee Act: a law passed in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. By collecting the fee, the FDA is required to meet benchmarks related to the speed of the NDA/BLA review process
8. PDUFA Date: deadlines for the FDA to approve new drugs, typically 10 months from NDA/BLA completions, drugs selected for priority review may be allotted 6 months
9. sBLA: supplemental Biologics License Application
10. sNDA: supplemental New Drug Application

References:

U.S. Food and Drug Administration. Center for Drug Evaluation and Research Advancing Health Through Innovation 2017 New Drug Therapy Approvals. Downloaded February 16,2018. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf?utm_campaign=Advancing%20Health%20through%20Innovation%3A%20New%20Drug%20Approvals%20and%20Other%20Drug%20Therapy%20Advances%20of%202017&utm_medium=email&utm_source=Eloqua

Pharma Intelligence Center Web Site. Accessed February 28, 2018. https://pharma.globaldata.com

U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Accessed February 28, 2018.  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

U.S. Food and Drug Administration. Novel Drug Approvals for 2017. Accessed February 28, 2018.  https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm