2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes.
| Tradename/Common Name | Indication for Use | NDA/ANDA Number | Applicant | Approval Date |
|---|---|---|---|---|
| Anticoagulant Sodium Citrate 4% w/v Solution, USP | Intended for use only with automated apheresis devices in the collection of human plasma or in performing therapeutic plasma exchange procedures. It is not to be infused directly into the donor. | 125697/0 | Laboratorios Grifols, S.A. Grifols Shared Services North America, Inc. 8368 U.S. Highway 70 West Clayton, NC 27520 |
10/25/2019 |
| 0.9% Sodium Chloride Injection USP Solution | A pre-attached subassembly component of the Fresenius Kabi apheresis kit for apheresis kit priming and/or for use as a replenishment fluid to maintain isovolemia in subjects undergoing an apheresis procedure. | 125695/0 | Fresenius Kabi AG Else-Kroner Strasse 1 D-61352 Bad Homburg Baden-Wurttemberg 61352 Germany |
09/05/2019 |
| InterSol Solution Platelet Additive Solution 3 |
This Prior Approval sNDA provides for the use of InterSol Solution with the Terumo Trima Accel Device. | 080041/75 | Fresenius Kabi Three Corporate Drive, Lake Zurich, IL 60047 |
5/22/2019 |