FDA advisory panels recommend Lotronex be put back on marketBMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7345.1053/a (Published 04 May 2002) Cite this as: BMJ 2002;324:1053
- Fred Charatan
Two advisory committees of the US Food and Drug Administration have jointly recommended that alosetron hydrochloride (Lotronex), voluntarily withdrawn in November 2000 by GlaxoSmithKline, should be put back on the market.
It is the first time in the FDA's history that an advisory panel has recommended that a banned drug (BMJ 2000;321: 1429) should be reintroduced.
GlaxoSmithKline said that it applied to the FDA for approval to allow the reintroduction of alosetron tablets under modified conditions …