Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 45

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 45
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 fiscal year, and an exception
from the product fee for a product that is the same as another product approved under an abbreviated pathway.

The FDA conducts a preliminary review of an NDA
within 60 days of its receipt and strives to inform the sponsor by the 74th day after the FDA’s receipt of the submission to determine
whether the application is sufficiently complete to permit substantive review. The FDA may request additional information rather than
accept an NDA for filing. In this event, the application must be resubmitted with additional information. The resubmitted application
is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth
substantive review. The FDA has agreed to certain performance goals in the review process of NDAs. Most such applications are meant to
be reviewed within ten months from the date of filing, and most applications for “priority review” products are meant to
be reviewed within six months of filing. The review process may be extended by the FDA for three additional months to consider new information
or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.

22

Before approving an NDA, the FDA typically will
inspect the facility or facilities where the product is or will be manufactured. These pre-approval inspections may cover all facilities
associated with an NDA submission, including drug component manufacturing (such as active pharmaceutical ingredients), finished drug
product manufacturing, and control testing laboratories. The FDA will not approve an application unless it determines that the manufacturing
processes and facilities comply with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Under
the FDA Reauthorization Act of 2017 (“FDARA”), the FDA must implement a protocol to expedite review of responses to inspection
reports pertaining to certain drug applications, including applications for drugs in a shortage or drugs for which approval is dependent
on remediation of conditions identified in the inspection report.

In addition, as a condition of approval, the
FDA may require an applicant to develop a REMS. REMS use risk minimization strategies beyond professional labeling to ensure that the
benefits of the product outweigh the potential risks. To determine whether a REMS is needed, the FDA will consider the size of the population
likely to use the product, seriousness of the disease, expected benefit