Treatment access
FDA approval of generic ARVs
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 |
| Abacavir, 300mg tablets | Strides Arcolab, India | 12 April 2010 |
| ddI (didanosine) 125, 200, 250 and 400mg. Delayed-release Capsules All four of the strengths will be packaged in HDPE bottles in 30’s and 500’s | Matrix, India
|
08 April 2010 |
| Tenofovir DF, 300mg tabs | Hetero, India | 06 April 2010 |
| Nevirapine tablets for oral suspension
50 mg, for children weighing >5 kg |
Aurobindo, India | 24 February 2010 |
| Efavirenz cross-scored tablets, 200 mg
(to be broken into two 100 mg or four 50 mg doses for paediatric dosing. |
Strides Arcolab, India | 12 February 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 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
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This brings the total of FDA approved generic drugs and formulations to 111 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
Links to external websites are current at time of posting but not maintained.