Saturday, November 03, 2007

FDA Approvals: Havrix, Venofer, Allegra

Food and Drug Management (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 tending of chronic idiopathic urticaria.

Hepatitis A Vaccine (Havrix) for Use in Infants Aged 1 Year and Older
On Oct. 18, the FDA approved an expanded meter reading 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 liking was based on data from a prospective, open, comparative, multicenter clinical endeavour in more than 1,000 healthy children, show the vaccine’s comparable contraceptive device 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 of time.
All children demonstrated a photographic film immune reaction to hepatitis A; topical anaesthetic and systemic adverse effects were comparable across all age groups.
The composition also showed that the hepatitis A vaccine retained its efficacy when administered concomitantly with Haemophilus b lockjaw toxoid conjugate vaccine (Hib conjugate vaccine).
According to a complement news liberation, the expanded meter reading is intended to allow healthcare providers to vaccinate younger children against hepatitis A at an age that may further help reduce the relative frequency of disease because cohort children often serve as carriers.
Later this time unit, the Advisory Administrative unit on Immunization Practices will meet to determine whether hepatitis A cicatrix requirements should be expanded to all children.
This is a part of article FDA Approvals: Havrix, Venofer, Allegra Taken from "Generic Allegra (Fexofenadine) Detailed Reviews" Information Blog

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