Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 131

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 131
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 Products in the United States

Licensure and Regulation of Pharmaceutical Products in the United States

We are currently developing product candidates
that are regulated as pharmaceutical (drug) products. In the United States, the development, approval, and commercialization of pharmaceutical
products are governed primarily by the Federal Food, Drug, and Cosmetic Act (FDCA) and related regulations enforced by the U.S. Food
and Drug Administration (FDA). Drug development programs may ultimately proceed toward one of two primary FDA approval pathways under
the Food, Drug, and Cosmetic Act: Section 505(b)(1) or Section 505(b)(2). A 505(b)(1) application is used for new drugs with full reports
of safety and efficacy data from studies conducted by the applicant. In contrast, a 505(b)(2) application may permit, subject to FDA
discretion, the sponsor to rely in part on data not developed by them, such as published literature or data from an already approved
drug, while still submitting original clinical or preclinical data required to support the proposed changes—such as a new formulation,
dosage form, or indication. The 505(b)(2) pathway may be considered for product candidates involving reformulation or repositioning of
existing drugs and, while it could potentially reduce development time and cost, there can be no assurance that the FDA will permit its
use or that it will ultimately result in approval. In addition to the FDCA, pharmaceutical products are subject to various other federal,
state, and local laws and regulations.

Our product candidates are in early stages of
development and have not yet been approved for marketing or commercial distribution in the United States.

To obtain FDA approval to market and distribute
a new pharmaceutical product in the United States, a sponsor must successfully complete the following regulatory steps:

| ● | Preclinical Testing: Conduct laboratory and animal studies to evaluate pharmacology, toxicology, and formulation, in accordance with the FDA’s Good Laboratory Practice (GLP) regulations, where applicable. |

| ● | Manufacturing Compliance: Develop and manufacture the drug substance and drug product in accordance with current Good Manufacturing Practice (cGMP) requirements, including analytical method validation, process validation, and stability testing. |

| ● | Investigational New Drug (IND) Application: Submit an IND to the FDA to obtain authorization to initiate human clinical trials. The IND must include preclinical data, manufacturing information, and a proposed clinical trial protocol. The IND must become effective (30-day FDA review period) before human