Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 139

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 139
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 activities involving the internet and social media. Promotional claims about a drug’s
safety or effectiveness are prohibited before the NDA is approved. Once a NDA is approved, the sponsor can make only those claims relating
to safety, efficacy, purity and potency that are in accordance with the provisions of the approved label. In the United States, healthcare
professionals are generally permitted to prescribe legally available drugs for uses that are not described in the product’s labeling
and that differ from those approved by the FDA. Such off-label uses are common across medical specialties. The FDA does not regulate the
practice of medicine or healthcare providers’ choice of treatments. However, FDA regulations do impose rigorous restrictions on
manufacturers’ communications of off-label uses. Additionally, promotional materials for prescription drug products must be submitted
to the FDA in conjunction with their first use.

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The FDA may require testing and surveillance programs
to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing
of a product based on the results of these post-marketing programs.

The FDA may withdraw product approval if compliance
with regulatory requirements and standards is not maintained or if issues occur after the product reaches the market. Later discovery
of previously unknown issues with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition
of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions and consequences
including:

| ● | restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, or complete withdrawal of the product from the market; |

| ● | the issuance of safety alerts, Dear Healthcare Provider letters, press releases or other |

| ● | refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals; |

| ● | product recall, seizure or detention, or refusal to permit the import or export of products; |

| ● | imposition of clinical holds on ongoing clinical trials; |

| ● | mandated modification of promotional materials and labeling and the issuance of corrective information; |

| ● | consent decrees, corporate integrity agreements, debarment or exclusion from federal |

| ● | fines, injunctions or the imposition of civil or criminal penalties. |

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