Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 143

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 143
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 orphan drug application, it may not be entitled to exclusivity. Orphan drug exclusivity does
not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.

The period of exclusivity begins on the date that
the marketing application is approved by the FDA and applies only to the indication for which the product has been designated. The FDA
may approve a second application for the same product for a different use or a second application for a clinically superior version of
the product for the same use. The FDA cannot, however, approve the same product made by another manufacturer for the same indication during
the market exclusivity period unless it has the consent of the sponsor, or the sponsor is unable to provide sufficient quantities.

The FDA has historically interpreted orphan drug
exclusivity as applying only to the specific approved indication, not the entire disease for which the orphan designation was granted.
However, in Catalyst Pharmaceuticals, Inc. v. Becerra (2021), the Eleventh Circuit ruled that exclusivity should cover all uses
within the designated orphan disease, rejecting the FDA’s narrower interpretation. In response, the FDA announced in January 2023
that it would follow the court’s ruling only within the Eleventh Circuit’s jurisdiction and maintain its longstanding approach
elsewhere. As a result, the scope of orphan drug exclusivity in the U.S. remains uncertain and may be further shaped by future litigation
or legislative action.

Development in Pediatric Patients

Under the Pediatric Research Equity Act of 2003,
a NDA must contain data that are adequate to assess the safety and effectiveness of the 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.
A sponsor who is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage
form, new dosing regimen or new route of administration must submit a Pediatric Study Plan (“PSP”) that contains 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 sponsor and the FDA must reach agreement on the PSP. The FDA or the applicant
may request an amendment to the plan at any time.

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