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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The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.