Important note: Information in this article was accurate in January 2009. The state of the art may have changed since the publication date.
FDA approval of generic ARVs
HIV Treat Bull - 2009 Jan-Feb;10(1/2): 17
Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.
d4T (stavudine) 15 mg, 20 mg, 30 mg and 40 mg| Drug and formulation | Manufacturer, Country | Approval date |
| Paediatric abacavir/3TC60mg/30mg tablets | Aurobindo, India | 19 December 2008 |
| FTC (emtricitabine) 200mg tablets | Matrix, India | 23 December 2008 |
| Aurobindo, India | 29 December 2008 | |
| d4T (stavudine) oral solution 1mg/mL | Aurobindo, India | 29 December 2008 |
| d4T (stavudine) 15 mg, 20 mg, 30 mg and 40 mg | Hetero, India | 29 December 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.htm.
Comment
The approval FDC of low dose (60/30mg) abacavir/3TC tablets is particularly important as this allows children with body weight down to 5kg. The GSK formulation, although approved for children, are the same dose as adult tablets (ie are ten-fold higher at 600/300mg).
They are scored, which is important for splitting half-doses, and are also dispersable in water. Both are intended for paediatric patients 3 months - 16 years of age.
The new formulations of d4T have more limited interest given the widespread shift away from d4T, even in WHO guidelines for ARV use in resource-limited countries. As d4T is now off-patent in the US, these generic formulations can also be used there.
This brings the total of FDA approved generic drugs and formulations to 78 since the programme started. An updated list of generic tentative approvals is available on the FDA website: http://www.fda.gov/oia/pepfar.htm.
Source: FDA list serve: http://www.fda.gov/oashi/aids/listserve/archive.html.
2009-02-10
IB2009-01-17
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