FDA Scolds Texas Drugmaker Over STD Product Promos
By Jeff Overley (January 28, 2014, 4:50 PM EST) -- Texas drugmaker Mission Pharmacal Co. distributed promotional materials for sexually transmitted disease medicine Tindamax that misled customers by overstating benefits and downplaying risks, according to a U.S. Food and Drug Administration letter released Monday.
The so-called untitled letter, which represents a gentler form of rebuke than a warning letter, focused largely on Mission's alleged failure to explicitly provide risk information in its sales sheet for Tindamax. Instead, the materials directed readers to separate full prescribing information, a two-tier form of communication that the FDA often criticizes.
For example, the sheet did not mention that pregnant women, nursing mothers and patients who...
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