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TREATMENT ACCESS

FDA generic approvals: copackaged generic Combivir and efavirenz; generic AZT 100mg capsules

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Two new FDA tentative approvals were granted to Aurobindo Pharma (India) for generic HIV products in March:

• to co-package a generic version of Combivir (AZT/3TC) with a generic efavirenz.
• for zidovudine 100 mg capsules.

Tentative approval means the co-packaged product “has met all required quality, safety and efficacy standards” but that it may not be sold in the United States because of existing patents. The co-packaged products may now be considered for purchase under PEPFAR, the President’s Emergency Plan for AIDS Relief.

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At least 11 generic ARVs have received tentative approval since this fast-track process was developed over a year ago. This scheme was specifically introduced in order that lower cost generic drugs would be able to be used in the PEPFAR prgramme.

It is not clear whether countries funded under PEPFAR are fully aware of these new options, and whether they are widely publicised within the PEPFAR programme.

A review of the extent and effectiveness of switching to generic drugs would be of great interest. Annecdotally, several programmes run in countries where ARV demand still far exceeds supply, are still reporting not changing to cheaper generic drugs.

Source: Food and Drug Administration list serve, March 8, 2006

Archive of past list serve announcements on the FDA web site:
http://www.fda.gov/oashi/aids/listserve/archive.html

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