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5 notable FDA decisions in 2014
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The FDA has already made several decisions in 2014 that may impact clinical practice — from approving a drug to treat a neglected tropical disease to granting priority review of a new combination therapy for chronic hepatitis C virus infection.
Infectious Disease News spotlights five FDA decisions made this year that clinicians should know to better inform and treat their patients.
FDA approves Impavido for leishmaniasis
The FDA recently approved the use of miltefosine to treat leishmaniasis. The drug had been granted fast-track designation, priority review and orphan product designation. Read more.
FDA Advisory committee deems tedizolid effective, safe for ABSSSI
The FDA’s Anti-Infective Drugs Advisory Committee voted unanimously that there is substantial evidence that tedizolid is safe and effective for the treatment of acute bacterial skin and skin structure infections caused by several organisms, including MRSA. Read more.
Dalbavancin found safe, effective for ABSSSI
The FDA Anti-Infective Drugs Advisory Committee has voted unanimously that dalbavancin has demonstrated substantial effectiveness and safety for the treatment of acute bacterial skin and skin structure infections caused by certain gram-positive organisms, including staphylococci and streptococci. Read more.
FDA grants priority review for ledipasvir/sofosbuvir
The FDA has granted a priority review to a new drug application for a combination of ledipasvir and sofosbuvir to treat chronic hepatitis C virus infection genotype 1. Read more.
Tdap vaccine age indication expanded to include 10-year-olds
Sanofi Pasteur announced that the FDA has expanded the approved age indication for its tetanus-diphtheria-acellular pertussis vaccine for patients aged 10 to 64 years, according to a company news release. Read more.