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FDA approvals of generic ARVS

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).

Links to other websites are current at date of posting but not maintained.