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Tag: fda
FDA Approves Efavirenz (Sustiva) for HIV+ Children Ages 3 Months to 3 Years
2013-05-04 18:02:12| Biotech - Topix.net
Below is an edited excerpt from a press release issued by Sustiva producer Bristol-Myers Squibb describing the approval in more detail.
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years
months
children
FDA Approves Mercks LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol
2013-05-03 21:06:15| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. LIPTRUZET Approved for Patients with Primary or Mixed Hyperlipidemia, as an Adjunct to Diet When Diet Alone Is Not Enough Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LIPTRUZET(ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Language: English Ticker Slug: Ticker: MRK Exchange: NYSE read more
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lower
cholesterol
fda
FDA Advisory Committee Recommends Approval Of BREO ELLIPTA For The Treatment Of COPD
2013-05-01 06:23:30| drugdiscoveryonline News Articles
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)
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treatment
committee
approval
FDA will investigate added caffeine in foods
2013-04-30 04:49:41| Food - Topix.net
This product image provided by the Wm. Wrigley Jr. Company shows the back of packaging showing the nutritional facts for Alert Energy Caffeine Gum.
Tags: added
investigate
foods
fda
Court Orders FDA to Implement Food Safety Rules
2013-04-29 21:44:00| National Hog Farmer
By P. Scott Shearer, Bockorny Group, Washington, DC The U.S. District Court in San Francisco has ordered the Food & Drug Administration (FDA) to establish a new timetable to implement regulations for the 2011 Food Safety Modernization Act (FSMA). read more
Tags: food
orders
rules
safety
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