FDA approval of generic ARVs
1 December 2012. Related: Treatment access.
Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted full and tentative approval for the following new generic ARV products.
| Drug and formulation | Manufacturer, Country | Approval date |
|---|---|---|
| Nevirapine/3TC/AZT zidovudine FDC scored tablets for Oral Suspension, 30 mg/50 mg/60 mg, for children weighing 5 to 25 kg. | Cipla, India | 16 October 2012 |
| Tenofovir/3TC tablets, 300 mg/300 mg for adults and pediatric patients 12 years of age and older and weighing at least 35 kg. | Macleods Pharmaceuticals Limited, India | 8 November 2012 |
| Efavirenz/tenofovir/3TC FDC tablets tablets, 600 mg/300 mg/300 mg, for adults and pediatric patients weighing at least 40 kg. | Hetero Labs, India | 8 November 2012 |
* full approval; FDC: Fixed Dose Combination
“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.
Fixed Dose Combinations are reviewed for PEPFAR under the FDA guidance titled “Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV”.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079742.pdf
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
An updated list of generic tentative approvals (now at 140) is available on the FDA website:
http://www.fda.gov/oia/pepfar.htm
Source: FDA list serve:
http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm