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|
|Atazanavir sulfate capsules, 300 mg||Emcur, India||19 August 2010|
|3TC/d4T FDC 150/30mg||Macleods, India||05 August 2010|
|AZT/3TC/nevirapine tablets for Oral Solution, 60 mg/30 mg/50 mg||Matrix Laboratories, India||08 July 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 programme for use outside the United States.
Effective patent dates are listed in the agencys 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
This brings the total of FDA approved generic drugs and formulations to 114 since the programme started. An updated list of generic tentative approvals is available on the FDA website: