McNeil Consumer Healthcare phasing out plant stanol ester-containing bars, saying consumers have "indicated a preference" for the brand's cholesterol-lowering spreads. Benecol SoftGel supplements, which launched in late 1999, are available in limited distribution; the J&J subsidiary discontinued the brand's salad dressings earlier this year (1"The Tan Sheet" May 1, In Brief). Single-serve packets of Benecol spread are now available solely through McNeil's Healthy Hospitals program, in which patients admitted for a cardiac event are given, at mealtime, Benecol and information about cholesterol. In food/drug/mass, Benecol and Lipton's Take Control continue to lag behind other margarines/spreads in the $1.29 bil. category, with each holding a 2.3% dollar share for the 52 weeks ended May 21, according to IRI
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
