logo
Share SHARE
FONT-SIZE Plus   Neg

Bristol-Myers Squibb Says FDA Oks Supplemental NDA For SUSTIVA - Quick Facts

Bristol-Myers Squibb Company (BMY: Quote), a biopharmaceutical company, Friday said the US Food And Drug Administration, or FDA, approved a supplemental new drug application or sNDA for SUSTIVA, including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. This approval offers a once-daily option as part of a regimen for this population and includes a 'capsule sprinkle' administration method for patients who cannot swallow capsules or tablets.

This sNDA was based on results from three open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of SUSTIVA in combination with other antiretroviral agents in 182 antiretroviral-naïve and -experienced HIV-1 infected pediatric patients (three months to 21 years of age) for a median of 123 weeks. Virologic and immunologic response was observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell count.

SUSTIVA is a non-nucleoside reverse transcriptase inhibitor or NNRTI that was originally approved in the U.S. in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kg.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
A remarkable increase in smartphone adoption has more Americans depending on their mobile devices to access the internet. The last moments of the doomed Germanwings plane, that was deliberately hit to the Alps, was recorded in a mobile phone, German newspaper Bild and French Magazine Paris Match reported. The video is presumed to be taken from the cabin, using a mobile device. The investigators recovered the memory card from the crash site, though the mobile was destroyed completely. However, there is no official con US Steel Corp. (X) Tuesday said it will "adjust operations" and temporarily idle a part of its Minntac plant in Mt. Iron, Minnesota, effective June 1. According to reports, the move would see about 700 employees laid off. The company said the decision was due to its current inventory levels and ongoing...
comments powered by Disqus
RELATED NEWS
Trade BMY now with 
Follow RTT