FDA's new approach to botanicals spurs research programs
The FDA's new approach to Chinese botanical therapies produced its first approval late last year. The agency OK'd Veregen from Germany's Medigene, an ointment for genital warts that is derived from green tea leaves. The FDA's new approach--which required the agency to hire herbal experts to provide expert guidance--is a sharp departure from its standard approval process, which requires researchers to identify the exact active ingredient that is responsible for a therapeutic response. And companies have responded by putting some 250 botanical therapies in the pipeline, according to The Wall Street Journal. The UK's Phynova, for example, has received approval to begin testing on a botanical drug for hepatitis.
- read this WSJ article on botanicals (sub. req.)