Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade BMY now with 

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.

Click here to receive FREE breaking news email alerts for Bristol-Myers Squibb Co. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Beverages giant Coca-Cola Co. reported Tuesday a profit for the third quarter that decreased 14 percent from last year, despite higher worldwide volumes, reflecting a revenue drop. Adjusted earnings per share matched analysts' expectations, even as quarterly revenues missed their estimates. Following the announcement, the company's shares are trading more than five percent lower in early deals. Apple Inc. said Monday that its fourth quarter profit rose 13% from last year, driven by strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly sales. At the same time, the company gave an upbeat revenue forecast for the current quarter, which includes the all important holiday season. Programmable chipmaker Xilinx Inc. (XLNX) said Thursday after the markets closed that its second quarter profit rose 21% from last year, helped by higher revenue and better cost control. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue....
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.