FDA approval of generic ARVs
1 June 2010. 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.
| Drug and formulation | Manufacturer, Country | Approval date |
| 3TC/d4T 150/30 mg tabs | Hetero, India | 17 May 2010 |
| abacavir, 300 mg tablets | Strides Arcolab, India | 12 May 2010 |
| ddI delayed-release capsules, 125 mg, 200 mg, 250 mg, and 400 mg | Matrix, India | 06 April 2010 |
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 agencys 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
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This brings the total of FDA approved generic drugs and formulations to 112 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: