FDA approves biotech drug for reducing symptoms of severe chickenpox infection
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said Friday.
The FDA announced the approval of Cangene Corp.’s Varizig (varicella zoster immune globulin [human]) for varicella zoster, the virus that causes chickenpox. The FDA said Varizig was the only FDA-approved immune globulin for the virus after exposure.
The drug is designed for people who are particularly vulnerable to the virus, including adults with weakened immune systems, pregnant women and infants exposed during pregnancy or after birth.
"This approval fills an unmet need by providing a treatment to lower the risk of severe, potentially fatal varicella infections in vulnerable patients," FDA Center for Biologics Evaluation and Research director Karen Midthun said.
FDA approves Tamiflu in children younger than 1 year
SILVER SPRING, Md. — The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.
The FDA announced the new approval for Genentech’s Tamiflu (oseltamivir). The agency said that while patients ages 1 year and older can receive the same dosage, those younger than 1 year must be dosed based on their exact weight.
"Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children," FDA Office of Antimicrobial Products director Edward Cox said. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."
FDA approves new drug for short bowel syndrome
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug to treat a condition that affects people who have had their intestines partially or completely removed, the agency said Friday.
The FDA announced the approval of NPS Pharmaceuticals’ Gattex (teduglutide) for daily injection in adults with short bowel syndrome who need additional nutrition from intravenous feeding. SBS results from partial or complete surgical removal of the small or large intestine, which can lead to poor absorption of fluids and nutrients from food.
Gattex is the third drug for SBS to receive FDA approval. The agency approved Merck KGaA’s Zorbitive (somatropin) in 2003 and Emmaus Medical’s Nutrestore (glutamine) in 2004.