This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.
|Tradename/Proper Name||Indication for Use||STN||Manufacturer/
|Is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.||125746/0||Janssen Biotech, Inc.
920 US Highway 202
P.O. Box 300
Raritan, NJ 08869
Lic. # 1864
COVID-19 Vaccine, mRNA
|Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older||125752/0||ModernaTX, Inc.
200 Technology Square
Cambridge, MA 02139
Lic. # 2256