FDA threatens enforcement action against two firms selling red yeast rice supplements adulterated with lovastatin - the active ingredient in Merck's Rx cholesterol-lowering drug Mevacor. Consumers should not purchase or consume Swanson Healthcare Products' Red Yeast Rice and Red Yeast Rice/Policosonal Complex or Sunburst Biorganics' Cholestrix since FDA testing revealed the presence of the statin, which can cause harmful side-effects such as muscle weakness and kidney issues and may interact with other medications, FDA announces Aug. 9. The agency determined the adulterated supplements are unapproved new drugs, sent warning letters to the companies marketing the products and threatens to employ enforcement actions, such as seizure of illegal products and criminal prosecution if the companies fail to resolve the violations immediately, according to the warning letters. In January 2005, Source Naturals received a courtesy letter from FDA for the same problem (1"The Tan Sheet" Jan. 24, 2005, In Brief)...

Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.

South Korea has formulated new detailed policy measures to support the formation of major bioclusters, which will offer tax and other incentives in a bid to lure foreign firms and talent.