In a cautionary letter released today the FDA warned Eli Lilly (Public, NYSE:LLY)and Company that they must cease to distribute specific advertising material as it is considered to contain false or misleading information.
The FDA found that the advertising mailer in question in that it overstated the efficacy of Cymbalta and omitted some of the most serious risk information associated with its use. The FDA felt that the claim that Cymbalta will "Help your DPNP patients experience less pain interference with overall functioning" was overstated and suggested patients with DPN who are treated with Cymllata would experience significantly less pain. This claim has not been substantiated by any evidence.
The company is working with the FDA "to gain a greater understanding of their concerns," Lilly spokesman Charlie McAtee said. Lilly will take action once it has "more clarity" on the agency's comments, he said.
[Source: CNNMoney]
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