Ft Lauderdale, Florida 1/13/2010 9:15:00 AM
News / Business

FDA Cites Eli Lilly (NYSE: LLY), Bayer, Amylin (NASDAQ: AMLN), Cephalon (NASDAQ: CEPH)

The Federal Drug Administration sent letters Tuesday to Eli Lilly (NYSE: LLY), Bayer, Amylin Pharmaceuticals (NASDAQ: AMLN) and Cephalon (NASDAQ: CEPH) for making inaccurate or incomplete statements while promoting their drugs, according to Associated Press.

 

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The letter to Lilly cites a print advertisement for the antidepressant Cymbalta. According to the FDA, Lilly's advertisement does not adequately display information about the drug's side effects, which is required for all pharmaceutical promotions.

 

The company said it is working to remove the materials from marketing circulation.

 

The FDA's letter to Cephalon is similar, stating that the company is missing risk information in their promotional cards for lymphoma drug Treanda.

 

In the letter to Amylin, the FDA said the company made misleading comments while promoting its diabetes drug Byetta at a conference in Washington D.C. last summer. Amylin co-markets Byetta with Lilly.

 

In addition, FDA regulators said Bayer's script for a presentation on its birth control implant Mirena "overstates the efficacy" and "presents unsubstantiated claims," according to the letter.

 

A spokeswoman for Bayer Healthcare Pharmaceuticals said the company discontinued the promotional program last February. She confirmed that the company received the letter Dec. 30 and will respond by Thursday Jan. 14, as requested by FDA.

 

The four letters were issued on separate dates between mid-December and early January.

 

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