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Libimax supplement a bit too potent
Nature & Health Co. announces a recall of its male enhancement formula after FDA analysis found samples of Libimax contained tadalafil, the active ingredient in Eli Lilly's Rx erectile dysfunction drug Cialis. FDA warns that tadalafil, in conjunction with nitrates found in prescription cholesterol drugs, can cause a dangerous drop in blood pressure. Brea, Calif.-based Nature & Health said April 27 the recalled product was sold in retail stores in California, Georgia, Illinois, Ohio and Texas. FDA has emphasized it will seize adulterated supplement products when firms fail to comply with recall requests (1"The Tan Sheet" July 28, 2008, p. 15)
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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.’
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As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.
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Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
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The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.