Important note: Information in this article was accurate in November 2009. The state of the art may have changed since the publication date.
FDA approval of generic ARVs
HIV Treat Bull - 2009 Nov/Dec;10(11/12): 22
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 |
| Efavirenz tablets 50, 100 and 200 mg tablets | Matrix, India | 24 November 2009 |
| Lopinavir/ritonavirtablets 200/50mg | Cipla, India | 20 November 2009 |
| 3TC/tenofovir DF300/300mg Fixed Dose Combination (FDC) | Hetero, India | 05 November 2009 |
“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.accessdata.fda.gov/scripts/cder/ob/default.cfm.
Comment
This brings the total of FDA approved generic drugs and formulations to 104 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/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm122951.htm.
2009-11-10
IB2009-11-22
©2009. I-BASE HIV Treatment Bulletin. Permission to reproduce courtesy of HIV i-Base, Third Floor East, Thrale House, 44-46 Southwark Street, London SE1 1UN - T: +44 (0) 20 7407 8488 F: +44 (0) 20 7407 8489
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in November 2009. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2009. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.