FDA approval of generic ARVs
24 October 2008. Related: Treatment access.
Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.
| Date | Drug | Company |
|---|---|---|
| 3 September 2008 | Abacavir 600mg/3TC300mg | Aurobindo, India |
| 12 September 2008 | Abacavir 60mg (scored) paediatric formulation | Aurobindo, India |
| 12 September 2008 | Tenofovir 300mg + 3TC 300mg | Matrix, India |
“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 also known as the Orange Book.
Comment
This brings the total of FDA approved generic drugs and formulations to 73 since the programme started.
Updated list of generic tentative approvals:
http://www.fda.gov/oia/pepfar.htm
Source: FDA list serve:
http://www.fda.gov/oashi/aids/listserve/archive.html
An archive of past list serve announcements is available on the FDA web site:
http://www.fda.gov/oashi/aids/listserve/archive.html