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Chemicon Inc. reg letter

Executive Summary

Firm received an Oct. 5 reg letter for manufacturing and distributing numerous prescription drugs, including minoxidil lotion (Upjohn's Rogaine) and tretinoin cream (Ortho's Retin-A). The drugs are "misbranded in that their labeling fails to bear adequate directions for use for the conditions for which the articles are represented and suggested, and they are not exempt from this requirement ... since the articles are new drugs ... and no approval of application ... is effective for the said articles of drugs." All of Chemicon's drugs are misbranded since the firm failed to register and list every drug in distribution, the reg letter says ....
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