Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 134

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 134
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 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 approval of the product for use in
adults, or full or partial waivers from the pediatric data requirements. The FDA must send a non-compliance letter to any sponsor that
fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.
Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation.

Pediatric Exclusivity

Pediatric exclusivity is a type of non-patent
marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing
protection to the term of any existing regulatory exclusivity, including orphan exclusivity. This six-month exclusivity may be granted
if a NDA sponsor submits pediatric data