FDA update on brand drugs for March 11, 2010

[chantell.reagan]

Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid by CSL Behring
Approval: for the treatment of Primary Immunodeficiency (PI)

•Link to FDA letter
•Link to prescribing information

Expanded indications/labeling changes:

Botox (onabotulinumtoxin A) by Allergan
Expanded indication: to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis

•Link to FDA press release 3/10

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER