Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 27

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 27
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A
drug can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to
existing exclusivity periods. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term,
may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request”
for such a study.

U.S.
Post-Approval Requirements for Drugs

Drugs
approved by FDA are subject to continuing regulation by the FDA, including, among other things, requirements relating to manufacturing
establishment registration and product listing, recordkeeping, periodic reporting, product sampling and distribution, reporting
of adverse experiences with the product, field alerts regarding issues with distributed product, promotion and advertising compliance,
which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”)
and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe approved products
for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively enforce the laws and
regulations prohibiting the promotion of off-label uses, as well as other advertising and promotion requirements, including not
only by company employees but also by agents of the company or those speaking on the company’s behalf, and a company that
is found to have improperly promoted may be subject to significant liability, including investigation by federal and state authorities.
Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, untitled letters,
corrective advertising, and potential civil and criminal penalties, including liabilities under the federal False Claims Act (the
“FCA”) where products obtain reimbursement under federal health care programs. Promotional materials for approved
drugs must be submitted to the FDA in conjunction with their first use or first publication, and for products approved under accelerated
approval prior to their first use. Further, if there are any modifications to the drug, including changes in indications, labeling
or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or NDA
supplement, which may require the development of additional data or preclinical studies and clinical trials.

The
FDA may withdraw approval of a product 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