Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 233

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 233
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 FDA review and approval. Certain modifications may require the NDA sponsor to
develop additional data or conduct additional nonclinical studies and clinical trials.

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There also are continuing, annual program fees for any marketed products. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies to assess compliance with cGMP requirements and other laws. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products. In addition, changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP requirements and impose reporting requirements on the NDA applicant and any third-party manufacturers involved in producing the approved drug product. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of quality control and quality assurance. The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems 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 requirements for post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS. Other potential consequences include, among other things:

| • |     | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market 
 or product recalls;                                                                                               |

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

| • |     | the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications 
 containing warnings or other safety information about the product;                                       |

| • |     | fines, warning letters, or untitled letters; |

| • |     | clinical holds on ongoing or planned clinical studies; |

| • |     | refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or 
 rev