China Clears Wuyi Drug Combining Herb Extracts, Pharmaceutical (China)
This article was originally published in PharmAsia News
China gave clearance to Wuyi International Pharmaceutical to market as early as January its new type of drug for treating hyperlipidemia. The company's CEO said the drug, Perilla Oil Capsule, includes extracts from Chinese herbs and reduces the length of treatment, compared with Western drugs. Lin Ou Wen said the company expects nearly U.S.$13 million in sales revenue next year. (Click here for more
You may also be interested in...
Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.