FDA approvals of generic ARVS
24 March 2014. Related: Treatment access.
The US Food and Drug Administration (FDA) has granted tentative (or full**) approval for the following new generic ARV products so far in 2014.
| Drug and formulation | Manufacturer, Country | Approval date |
| atazanavir (100 mg, 150 mg,
200 mg and 300 mg) capsules |
Aurobindo, India | 31 Jan 2014 |
| 3TC/AZT (150 mg/300 mg tablet) ** | Hetero Labs, India | 3 Feb 2014 |
| tenofovir/FTC (300 mg/200 mg) tablets | Cipla, India | 26 Feb 2014 |
| tenofovir/3TC (300 mg/ 300 mg)
+ copackaged nevirapine (200mg) |
Hetero labs, India | 14 Mar 2014 |
| atazanavir/ritonavir (300 mg/100 mg) tablets | Emcure, India | 17 Mar 2014 |
** full approval, otherwise all tentative 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. Full approval means the patent has expired for the original compounds and the product can be used in the US.
An updated list of generic tentative approvals (now at 170) is available on the FDA website:
http://www.fda.gov/oia/pepfar.htm
A list of generic ARVs now available for use inside the US is also online:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm
Source: FDA list serve (various dates, as approved).