Although new botanical drugs pose many challenges for both industry and the FDA, approval of the first botanical prescription drug shows they can be successfully met.
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References
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry. Botanical Drug Products (FDA, DC, June 2004). <http://www.fda.gov/cder/guidance/4592fnl.pdf>
Wu, K.M. et al. Toxicol. Lett. 111, 199–202 (2000).
Wu, K.M. et al. Am. J. Ther. 11, 213–217 (2004).
Murayama, M., Takao, M., Bando, H. & Amiya, T. J. Ethnopharmacol. 35, 159–164 (1991).
Lindenmuth, G.F. & Lindenmuth, E.B. J. Altern. Complement. Med. 6, 327–334 (2000).
Turner, R.B., Bauer, R., Woelkart, K., Hulsey, T.C. & Gangemi, J.D. N. Engl. J. Med. 353, 341–348 (2005).
Hypericum Depression Trial Study Group. J. Am. Med. Assoc. 287, 1807–1814 (2002).
Shelton, R.C. et al. J. Am. Med. Assoc. 285, 1978–1986 (2001).
Kasper, S., Anghelescu, I.G., Szegedi, A., Dienel, A. & Kieser, M. BMC Med. 4, 14 (2006).
Nakachi, K., Eguchi, H. & Imai, K. Ageing Res. Rev. 2, 1–10 (2003).
Lin, Y.S., Tsai, Y.J., Tsay, J.S. & Lin, J.K. J. Agric. Food Chem. 51, 1864–1873 (2003).
Jiang, X. New Medical College, Encyclopedia of Chinese Materia Medica (Zhong Yao Da Ci Dian) (Shanghai People's Press, Shanghai, China, 1977).
Stevens, T., Qadri, A. & Zein, N.N. Ann. Intern. Med. 142, 477–478 (2005).
Gloro, R. et al. Eur. J. Gastroenterol. Hepatol. 17, 1135–1137 (2005).
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The authors thank L. Vaccari for assistance in preparing an early draft.
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Chen, S., Dou, J., Temple, R. et al. New therapies from old medicines. Nat Biotechnol 26, 1077–1083 (2008). https://doi.org/10.1038/nbt1008-1077
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DOI: https://doi.org/10.1038/nbt1008-1077