HIV Therapy

FDA issues warning letter regarding Norvir

Published in Medical Letter on the CDC and FDA, July 11th, 2004

Abbott Laboratories has received a warning letter from the U.S. Food and Drug Administration's Division of Drug Marketing Advertising and Communications (DDMAC) outlining concerns related to the website and other specified materials for Norvir (ritonavir capsules) Soft Gelatin capsules.

FDA's letter addresses two primary concerns. The first pertains to a cost comparison chart describing the daily cost of common anti-retroviral therapies. FDA raised concerns that this chart could be interpreted to imply that Norvir can be used as monotherapy at a sub-therapeutic dose.

Abbott developed this chart to respond to concerns regarding Abbott's re-pricing of...

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Source: Medical Letter on the CDC and FDA (2004-07-11)

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