Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 66

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 66
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 CT3000 may also be
subject to a post-approval safety monitoring program, limitations on the approved indicated uses for which the product may be
marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase
4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. For example, the holder of an
approved NDA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the
NDA. The holder of an approved NDA also must submit new or supplemental applications and obtain FDA approval for certain changes
to the approved product, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA
rules and are subject to FDA review, in addition to other potentially applicable federal and state laws.

In
addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections
by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA
or foreign marketing application. If we, or a regulatory authority, discover previously unknown problems with a product, such
as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees
with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product,
the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If
we fail to comply with applicable regulatory requirements following approval of CC8464, CT2000, CT3000 or any future compound,
a regulatory authority may:

    ●
    issue a warning
    letter asserting that we are in violation of the law;

    ●
    seek an injunction
    or impose administrative, civil or criminal penalties or monetary fines;

    ●
    suspend or withdraw
    regulatory approval;

    ●
    suspend any ongoing
    clinical trials;

    ●
    refuse to approve
    a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;

    ●
    restrict the marketing
    or manufacturing of the product;

    ●
    seize or detain
    the product or otherwise require the withdrawal of the product from the market;

    ●
    refuse to permit
    the import or export of compounds; or

    ●
    refuse to allow
    us to enter into supply contracts, including government contracts