The Food and Drug Administration May 5 released violation letters that it sent to Shire Development Inc. and Genentech Inc. over promotional materials for three prescription drugs.
The agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC) sent so-called untitled letters to Shire regarding sales brochures for Lialda (mesalamine delayed-release capsules) and Pentasa (mesalamine controlled-release capsules), and to Genentech regarding professional table-top panels for Rituxan (rituximab injection).
An untitled letter cites violations that do not meet the threshold of regulatory significance for an FDA warning letter, according to the agency’s regulatory procedures manual.
FDA asked the companies to stop distributing ...
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