RJ Health Monthly Specialty FDA Actions Newsletter – September 2018 – Volume 1 – Number 9

In September there were a total of six new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had assigned six new products for review. Finally, there was one complete response letter with no current data on expected resubmission date.

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 – New FDA drug approvals in the previous month

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

*Injectable designation applies to drugs that could be administered intravenously and subcutaneously.

1. Extension of the Prescription Drug User Fee Act (PDUFA) goal date from October 5, 2018 to January 5, 2019.
2. Extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.

Looking Ahead – Anticipated FDA actions for specialty drugs in 2018

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 June 29, 2018. https://www.fda.gov/…/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf

Pharma Intelligence Center Web Site. Accessed October 1, 2018. https://pharma.globaldata.com

U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Accessed October 1, 2018.  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

U.S. Food and Drug Administration. Novel Drug Approvals for 2017. Accessed September 7, 2018.  https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm