FDA approves Barr Pharmaceuticals and subsidiary Pliva's generic version of Bristol-Meyers Squibb's cholesterol drug Pravachol Nov. 28. The Woodcliff Lake, N.J.-based company says it plans to launch 10 mg, 20 mg and 40 mg of the pravastatin product immediately. Barr also says Pliva received tentative approval for its pravastatin 80 mg and plans to launch it following the expiration of a competitor's 180-day generic drug exclusivity period. Watson announced in May its launch of a generic Pravachol following FDA approval of Teva's ANDA (1"The Tan Sheet" May 1, 2006, p. 12)...
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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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European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
