Risperdal “Dear Doctor” letter
Executive Summary
Janssen Risperdal "Dear Doctor" letter issued July 21 corrects company's Nov. 10 letter concerning the relationship between the atypical antipsychotic and hyperglycemia and diabetes. The November letter elicited a warning letter from FDA April 19 (1"The Pink Sheet" May 3, 2004, p. 44). Janssen's letter states that FDA's "warning letter concludes that Janssen...omitted material information about Risperdal, minimized potentially fatal risks, and made misleading claims suggesting superior safety to other atypical antipsychotics without substantiation"...
Janssen Risperdal "Dear Doctor" letter issued July 21 corrects company's Nov. 10 letter concerning the relationship between the atypical antipsychotic and hyperglycemia and diabetes. The November letter elicited a warning letter from FDA April 19 (1 , p. 44). Janssen's letter states that FDA's "warning letter concludes that Janssen...omitted material information about Risperdal, minimized potentially fatal risks, and made misleading claims suggesting superior safety to other atypical antipsychotics without substantiation".... |