Food and Drug Administration - October 25, 2006
Richard Klein & Kimberly Struble

The Food and Drug Administration (FDA) announced, on October 18, 2006, the availability of a guidance for industry entitled "Fixed Dose Combinations (FDC), Co-Packaged Drug Products and Single Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV." The guidance encourages sponsors to develop various drug product versions of previously approved antiretroviral drugs and encourages sponsors to submit drug applications for these products to FDA for review. The availability of a wide range of safe and effective antiretroviral drug products is hoped to facilitate a wider distribution of anti-HIV drugs to better meet the demands of the global HIV/AIDS pandemic.

The draft version of this guidance entitled "Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV," was first posted on May 2004.

The guidance has been updated to address public comments to the draft version. Significant changes to the draft are: 1) the inclusion of single entity versions, in addition to combination products, in the expedited FDA review pathway for these products 2) the addition of tables that supply references supporting the clinical efficacy and safety of antiretroviral combinations 3) the inclusion of more details and clarification on the amount and type of data that should be submitted in a drug application to support a potential approval or tentative approval.

The full guidance is available on the FDA web site www.fda.gov/cder/guidance/6360fnl.pdf (343 KB).

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
061025
FD061005

SOURCE: Food and Drug Administration (FDA).

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