Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 55

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 55
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 must also send notice of the Paragraph IV certification to the NDA and patent holders once
the ANDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response
to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of a Paragraph
IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months after the receipt of the Paragraph
IV notice, expiration of the patent, or a decision in the infringement case that is favorable to the ANDA applicant.

Pediatric Studies and Exclusivity 

Under the Pediatric Research Equity Act of 2003,
an NDA or supplement thereto must contain data that are adequate to assess the safety and effectiveness of the drug product for the claimed
indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which
the product is safe and effective. With enactment of the Food and Drug Safety and Innovation Act (“FDASIA”), in 2012, sponsors
must also submit pediatric study plans prior to the assessment data. Those plans must contain an outline of the proposed pediatric study
or studies the applicant plans to conduct, including study objectives and design, any deferral or waiver requests, and other information
required by regulation. The applicant, the FDA, and the FDA’s internal review committee must then review the information submitted,
consult with each other, and agree upon a final plan. The FDA or the applicant may request an amendment to the plan at any time. For
drugs intended to treat a serious or life-threatening disease or condition, the FDA must, upon the request of an applicant, meet to discuss
preparation of the initial pediatric study plan or to discuss deferral or waiver of pediatric assessments.

In addition, FDARA requires the FDA to meet early
in the development process to discuss pediatric study plans with drug sponsors. The legislation requires the FDA to meet with drug sponsors
no later than the end-of-phase 1 meeting for serious or life-threatening diseases and by no later than 90 days after the FDA’s
receipt of the study plan.

The FDA may, on its own initiative or at the
request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in
adults, or full or partial waivers from the pediatric data requirements. Additional requirements and procedures relating to deferral
requests and requests for extension of