Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 98

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 98
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 its product candidate or any future product candidate, even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, including any requirement to implement a Risk Evaluation and Mitigation Strategies (REMS). If a product candidate receives marketing approval, the accompanying label may limit the approved use of Cara’s drug, which could limit sales of the product. The FDA or other regulatory authorities may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. The FDA and other regulatory authorities closely regulate the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if Cara does not market its products for their approved indications, Cara may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act or equivalent regulations outside the United States relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws. In addition, later discovery of previously unknown AEs or other problems with its products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

| ● | restrictions on the products, manufacturers, manufacturing facilities or manufacturing process; |

| ● | imposition of restrictions on operations, including costly new manufacturing requirements; |

| ● | restrictions on the labeling or marketing of a product; |

| ● | restrictions on product distribution or use; |

| ● | requirements to conduct post-marketing studies or clinical trials; |

| ● | warning letters; |

| ● | withdrawal of the products from the market; |

| ● | refusal to approve pending applications or supplements to approved applications that Cara submits; |

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| ● | recall of products and publicity requirements; |

| ● | fines, restitution or disgorgement of profits or revenues; |

| ● | suspension or withdrawal of marketing or regulatory approvals; |

| ● | refusal to permit the import or export of Cara’s products; |

| ● | product seizure, detentions or import bans; or |

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

The FDA’s or other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory