FDA Approvals: Havrix, Venofer, Allegra. Part 1

Oct. 20, 2007 — The U.S.
Food and Drug Presidency (FDA) has approved a hepatitis A vaccine for
use in children aged one year and older; iron sucrose shot for use in
peritoneal dialysis-dependent patients with chronic kidney disease who
are receiving erythropoietin therapy; and a once-daily fexofenadine HCl
regimen for the care of chronic idiopathic urticaria.

On
Oct. 18, the FDA approved an expanded communication for a hepatitis A
vaccine (Havrix, made by GlaxoSmithKline), allowing its use in children
aged 12 months and older.
The vaccine was previously approved for use in children and adolescents
aged 2 to 18 geezerhood.

The
favorable reception was based on data from a prospective, open,
comparative, multicenter clinical tryout in more than 1,000 healthy
children, exhibit the vaccine’s comparable status and immunogenicity
when administered in two doses (720 El.U/0.5 mL on a newborn and
six-month schedule) starting at age 11 to 13 months, 15 to 18 months,
and two period.
All children demonstrated a photographic film immune body process to
hepatitis A; local anaesthetic and systemic adverse effects were
comparable across all age groups.
This is a part of article FDA Approvals: Havrix, Venofer, Allegra. Part 1 Taken from "Generic Allegra (Fexofenadine) Detailed Reviews" Information Blog