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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.
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Advocacy group says proposed compounding regulations would endanger public health
WASHINGTON — An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.
In a letter sent to Department of Health and Human Services secretary Kathleen Sebelius, Public Citizen criticized Food and Drug Administration commissioner Margaret Hamburg for "both undermining her agency's authority in congressional testimony last month and offering a plan that would effectively weaken the agency's oversight of drug manufacturing."