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FDA Approval of Generic ARVs

November/December 2012

Since the last issue of HTB, the U.S. 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."

Effective patent dates are listed in the agency's publication titled "Approved Drug Products With Therapeutic Equivalence Evaluations," also known as the "Orange Book."

An updated list of generic tentative approvals (now at 140) is available on the FDA website.

Source: FDA list serve.

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

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