2009 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
- Complete List of Currently Licensed Products and Establishments
- Transfer of Therapeutic Products to CDER
| Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|---|
| Rotarix Rotavirus Vaccine, Live, Oral, |
To update the Prescribing Information | 125265/126 | GlaxoSmithKline Biologicals 2301 Renaissance Blvd. P.O. Box 61540 King of Prussia , PA 19406-2772 License 1617 |
2/5/2009 |
| ORTHO T. cruzi ELISA Test System Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen |
Revise the package insert to include adding cadaveric specimens under the Intended Use section and changes to the Specimen Collection and Preparation section by adding Serum Separator Tube (SST) samples, elevated total protein, HAMA, and heterophilic antibodies specimens, as well as the addition of a new 192 test kit configuration. | 125161/23 | Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202 Raritan , NJ 08869 |
4/8/2009 |
| Fluarix Influenza Virus Vaccine |
To include a thimerosal-free formulation in single-dose prefilled syringes and related changes in the labeling. | 125127/314 | GlaxoSmithKline Biologicals 2301 Renaissance Boulevard Building 510, P.O. Box 61540 King of Prussia, PA 19406-2772 License 1617 |
4/1/2009 |
Infanrix |
Revisions to the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX and updated safety and immunogenicity data on the concomitant administration of INFANRIX with other recommended vaccines | 103647/5196 | GlaxoSmithKline Biologicals |
3/12/2009 |
| RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent |
To update the Patient Product Information and Prescribing Information. | 125122/524 | Merck & Co., Inc. P.O. Box 1000 UG2D-68 North Wales, PA 19454-1099 License 0002 |
2/5/2009 |
| ADACEL Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed |
To revise the package insert to include revision of the placement of
information
regarding latex content of the product. |
125111/193 | Sanofi Pasteur, Limited 1755 Steeles Avenue West Toronto , Ontario Canada License 1726 |
1/16/2009 |