Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 140

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 140
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 orphan designation receives
the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare
disease or condition for which it was designated, the product generally will receive orphan drug exclusivity. Orphan drug exclusivity
means that the FDA may not approve another sponsor’s marketing application for the same product for the same indication for seven years,
except in certain limited circumstances. If a product designated as an orphan drug ultimately receives marketing approval for an indication
broader than what was designated in its 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