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Lopinavir/Ritonavir (Kaletra/Aluvia)

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US FDA Updates

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Last Update: December 15, 2007
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US FDA Updates

NEWS RELEASE
FDA approved a new half-strength Kaletra tablet formulation. Each film-coated tablet contains
100 mg lopinavir and 25 mg ritonavir. The major changes to the label include clear instructions
regarding the importance of accurate calculation of the dose of Kaletra to minimize the risk for
medication errors and overdose or under dose, and the addition of tablet dosing to section 2.2
Pediatric Patients as described in the pdf attachment.
US FDA November 16, 2007

NEWS RELEASE
Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra
(lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Abbott Laboratories November 12, 2007

FULL-TEXT DOCUMENT
Kaletra (lopinavir/ritonavir) Product Label Update
USFDA May 23, 2007
News Release

FULL-TEXT DOCUMENT
FDA Approval for New Kaletra (lopinavir/ritonavir) Tablet Formulation for HIV Patients
Abbott Laboratories October 31, 2005

FULL-TEXT DOCUMENT
FDA Approves KALETRA 800/200mg once-daily administration for the treatment of HIV-infection in
therapy-naīve adult patients,
USFDA April 29, 2005
News Release

FULL-TEXT DOCUMENT
Norvir (ritonavir) and Kaletra (lopinavir/ritonavir) package inserts updated to include
information regarding interactions with fluticasone
FDA
March 30, 2005
News Release

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