Healthy Skepticism Library item: 16287

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Publication type: Electronic Source

FDA Issues Warning Letters to Several, Including Allergan, Galderma Laboratories and Johnson & Johnson Pharmaceutical Research & Development
PharmaLive 2009 Aug 22
http://pharmalive.com/news/index.cfm?articleID=646850

Full text:

The FDA has posted to its website warning letters it sent to companies and individuals regarding either misleading information about their marketed products or objectionable conditions. The agency said professional visual aids from

Galderma Laboratories for Tri-Luma® Cream “recommend or suggest uses for Tri-Luma that have not been approved by FDA, and thus create new “intended uses” for the drug for which the product lacks adequate directions, broaden the indication for Tri-Luma, and omit and minimize important risk information for the drug. “ Also, the FDA told Allergan its journal ad for Aczone “is false or misleading because it overstates the efficacy of ACZONE, and omits material facts and important risk information associated with the use of the product.”
The FDA sent a warning letter to Johnson & Johnson Pharmaceutical Research & Development “to inform you of objectionable conditions found during the U.S. Food and Drug Administration’s (FDA) investigation into Johnson & Johnson Pharmaceutical Research & Development’s (hereafter referred to as J & J PRD) role as sponsor of Study.”

Antibioticos do Brasil Uda. also received a warning letter from the FDA because,“The inspection revealed significant deviations from U.S. current good manufacturing practice (CGMP) regulations (Title 21, Code of Federal Regulations, Parts 210 and 211) in the manufacture of both sterile active pharmaceutical ingredients (APIs) and finished dosage products.”