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.
|Tradename/Proper Name||Indication for Use||STN||Manufacturer/
|To include a new indication for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.||125643/248||Kite Pharma, Inc.
Santa Monica, CA 90404
Lic. # 2064
|To extend the use of FLUCELVAX QUADRIVALENT manufactured at the Holly Springs, NC and -------(b)(4)------ facilities to persons 2 years of age and older.||125408/329||Seqirus Inc.
50 Hampshire Street, 9th Floor
Cambridge, MA 02139
Lic. # 2049
Immune Globulin Intravenous (Human)-ifas 10%
|Include the following: 1. a new indication for the treatment of adults 18 years of age and older with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment, and
2. to remove the distinction between new and experienced patients in section 2.1 in the prescribing information label.
|125587/70||Octapharma Pharmazeutika Produktionsges.m.b.H
117 West Century Rd.
Paramus, NJ 07652
Lic. # 1646
Antihemophilic Factor (Recombinant), Full Length
|To provide the Clinical Study Report (CSR) for Postmarketing Commitment #1 noted in the approval letter for STN BL 125574/0 and to update Section 6 of the Prescribing Information to include information related to inhibitor development in previously untreated patients with hemophilia A.||125574/400||Bayer HealthCare LLC
100 Bayer Boulevard
P.O. Box 915
Whippany, NJ 07981-0915
Lic. # 0008