Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV
This guidance is intended to encourage sponsors to submit applications to the Food and Drug Administration (FDA) for approval of fixed dose combination (FDC) and copackaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).2 The guidance seeks to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. Different considerations apply depending on whether (1) a sponsor owns or has a right of reference to all of the data required to support an application or (2) whether a sponsor plans to rely on literature or FDA’s findings of safety and effectiveness for an approved drug. This guidance addresses the issues associated with these different scenarios. Although this guidance focuses on FDC and co-packaged products, the principles outlined in this guidance also apply to singleingredient copies of antiretroviral drugs that are components of the regimens listed in Appendix B. On a case-by-case basis, these single-ingredient copies may be reviewed in an expedited time frame. The guidance provides scientific and technical details on the submission of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for both single and combination products.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.