FDA approval of generic ARVs
1 April 2011. Related: Treatment access.
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 |
|---|---|---|
| FTC (emtricitabine) 200 mg capsules | Cipla, India | 29 March 2011 |
| tenofovir/3TC 300 mg/300 mg FDC tablet | Cipla, India | 04 March 2011 |
| abacavir scored tablets for oral suspension, 60 mg | Cipla, India | 04 March 2011 |
| AZT 100 mg dispersible tablets (paediatric) | Matrix, India | 23 February 2011 |
| abacavir oral Solution, 20 mg/mL | Cipla, India | 16 February 2011 |
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. This document was developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079742.pdf
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
An updated list of generic tentative approvals 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