Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR.” This draft guidance provides recommendations for applications for single-entity antiretroviral (ARV) and ARV fixed-combination (FC) drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1) infection that are intended for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR). Specifically, this draft guidance addresses versions of ARV drug products for which the individual ARV drug product components are already FDA-approved and for which substantial evidence of safety and efficacy of the specific drug product or combination drug product already exists. When finalized, this draft guidance will replace the previous final guidance for industry entitled “Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV” issued in October 2006.
Scope & Applicability
Product Classes
7ARV drug products for HIV treatment or prevention
Antiretroviral drug products for HIV treatment; eligible for procurement under PEPFAR
Drug product containing two or more active ingredients; Drug products containing multiple active ingredients
two or more antiretroviral drugs combined in a single dosage form
SE versions of previously approved antiretrovirals
Single-entity antiretroviral drug products needed under PEPFAR
Fixed-combination antiretroviral drug products needed under PEPFAR
Stakeholders
3Addition of a new manufacturing site
Entity that owns and maintains a Drug Master File
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
7CMC changes after tentative approval; shelf-life period supported by stability data; proposing to extend the expiration dating period for the drug product
hot and dry or hot and humid conditions
Categorization for pediatric dosing recommendations
Changes with minimal potential to adversely affect drug identity, strength, quality, purity, or potency.
Change with moderate potential to affect product quality
Change with high potential to affect product quality
Statutory standard for drug approval and retention
Identified Hazards
Hazards
1Structural alert suggesting potential DNA damage
Related CFR Sections (12)
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR314.60§ 314.60 Amendments to an unapproved NDA, supplement, or resubmission.
(a) Submission of NDA. FDA generally assumes that when an original NDA, supplement to an approved NDA, or resubmission of an NDA or supplement is submitted to the Agency for review, the applicant believes that the Agency can approve the NDA, supplement, or resubmission as submitted. However, the appRead full regulation →
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR314.105§ 314.105 Approval of an NDA and an ANDA.
(a) FDA will approve an NDA and send the applicant an approval letter if none of the reasons in § 314.125 for refusing to approve the NDA applies. FDA will issue a tentative approval letter if an NDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but caRead full regulation →
- 21CFR314.108§ 314.108 New drug product exclusivity.
(a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.93§ 314.93 Petition to request a change from a listed drug.
(a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
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See Also (8)
- How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry (Status: Final)
- Development of New Stereoisomeric Drugs (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation (Status: Draft)
- Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Status: Draft)
- Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (Status: Draft)
- Influenza: Developing Drugs for Treatment and/or Prophylaxis (Status: Final)
- Codevelopment of Two or More New Investigational Drugs for Use in Combination (Status: Final)