Important note: Information in this article was accurate in May 2008. The state of the art may have changed since the publication date.
FDA approval of generic ARVs
HIV Treat Bull - 2008 May-June;9(5/6):25
Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.
| Drug and formulation | Manufacturer, Country | Approval date |
| d4T (40mg) + 3TC + nevirapine | Strides, India | 20 March 2008 |
| d4T (30mg) + 3TC + nevirapine | Strides, India | 20 March 2008 |
| AZT+3TC (300/150mg) | Hetero, India | 25 March 2008 |
| AZT (300mg) | Hetero, India | 25 March 2008 |
| FTC (emtricitabine) | Aurobindo, India | 9 May 2008 |
“Tentative Approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.
Effective patent dates are listed in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book:
http://www.fda.gov/cder/orange/default.htmComment
This brings the total of FDA approved generic drugs and formulations to 67 since the programme started. An updated list of generic tentative approvals is available on the FDA website:
http://www.fda.gov/oia/pepfar.htmSource: FDA list serve:
http://www.fda.gov/oashi/aids/listserve/archive.htmlAn archive of past list serve announcements is available on the FDA web site:
http://www.fda.gov/oashi/aids/listserve/archive.html2008-05-10
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