A recent letter from the Food and Drug Administration told drugmaker Pernix Therapeutics Holdings Inc. that a “webpage” for Cedax is false or misleading, due to omission of risk information.
The FDA’s “untitled” letter said the online material for Cedax (ceftibuten), which is indicated for certain infections, misbrands the drug. The letter is addressed to Pernix’s Solana Beach, Calif., office, but the company’s website says Pernix is based in Houston.
The agency’s letter is dated Dec. 20, 2013. A footnote in the letter said the pernixtx.com website was last visited in late June 2013.
Among the problems the agency found ...
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