KV Pharmaceutical e-mail alert overstated drug efficacy

The FDA says a KV Pharmaceutical e-mail alert announcing the availability of Clindesse on a formulary overstated and misrepresented the efficacy of the drug, which is indicated for treating bacterial vaginosis. The FDA says the e-mail presents unsubstantiated superiority and patient compliance claims, and minimizes the risks and limitations.

Next Article in Legal/Regulatory