Findings from the searched approval packages (as of 2026-02-19)

Across the documents reviewed in your dataset, no example was found that satisfies all three of your required elements simultaneously:

1. Priority Review granted
2. The “significant improvement” rationale (or equivalent Priority Review justification) explicitly includes a switch from an injectable dosage form (IV/IM/SC, infusion, etc.) to an oral dosage form
3. The rationale explicitly cites convenience/ease of administration (e.g., avoiding injections/infusions, at-home administration, reduced treatment burden, improved adherence) as part of that significant-improvement argument

In other words: Priority Review + “significant improvement” + convenience language does appear in the dataset, and injectable and oral routes appear in some files, but the specific “injectable → oral for convenience” linkage is not explicitly documented in the Priority Review rationale in the excerpts provided.

Closest match in the dataset: “convenience/compliance” explicitly tied to Priority Review—but not injectable → oral

ATryn (Antithrombin (Recombinant)) — Priority Review recommendation with convenience/compliance language (but still IV)

• The memo includes an explicit statement tying Priority Review to improvements in “compliance or convenience”: “improvement in some factors such as compliance or convenience…” as part of the recommendation to grant Priority Review ³⁶⁰.
• However, the product is described as intravenous infusion/continuous infusion (i.e., still injectable/parenteral) and no oral dosage form is described ³⁶².
• Therefore, it does not meet your injectable→oral switch requirement, even though it is a strong example of convenience being invoked in a Priority Review justification ³⁶⁰³⁶².

Examples where Priority Review was granted and convenience/administration benefits are discussed—but not as injectable → oral “significant improvement”

Aptivus (tipranavir) — Priority Review tied to dosing flexibility (oral solution + capsule), not injectable → oral

• Priority Review is documented ²⁶⁶²⁶⁹.
• Rationale includes that the new oral solution plus capsule provides “dosing flexibility” for children, in the context of limited treatment options ²⁶⁷.
• But there is no prior injectable formulation described and no injectable→oral switch presented as the significant improvement ^267264516.

Nymalize (nimodipine oral solution) — Priority Review granted; administration facilitation and avoidance of IV medication errors discussed, but not “injectable → oral switch”

• Priority Review is explicitly stated ⁹³⁹⁹⁴⁵.
• The oral solution was developed to facilitate administration (e.g., NG tube use) and to reduce catastrophic errors where extracted capsule contents were erroneously administered intravenously, causing deaths ^193916018.
• This is a strong administration/safety improvement narrative, but it is capsule → oral solution, not injectable → oral ¹⁴³²⁴. The IV references are about wrong-route errors, not a prior approved injectable dosage form being replaced ^193916018.

Vaxchora (cholera vaccine, live, oral) — Priority Review with “significant improvement” language, but not tied to route convenience or injectable → oral

• Priority Review granted; “significant improvement” is explicitly stated as improved effectiveness for prevention ¹¹²⁷.
• The product is oral, but the rationale does not cite convenience or an injectable→oral switch ^1127128.

Examples where convenience and “significant improvement” concepts appear—but the product is not an injectable → oral switch (or Priority Review not granted)

Zithromax (azithromycin) — sponsor explicitly cites convenience vs IM injection in a Priority Review request, but Priority Review grant not shown

• The sponsor’s Priority Review request explicitly cites “the convenience of oral administration” compared to ceftriaxone IM injection, and ties this to compliance and single-dose therapy ⁶⁸².
• However, the provided excerpts do not show FDA granting Priority Review for this submission (it appears Standard in the provided checklist) ²⁹⁴.
• This is very close to your desired argument structure (injectable comparator → oral convenience), but it is not a confirmed “Priority Review granted” example in the supplied pages ⁶⁸²²⁹⁴.

EPANED KIT (enalapril powder for oral solution) — convenience argued for Priority Review, but FDA denied Priority Review

• Sponsor argued convenience (no refrigeration, no shaking, standardized dosing) as the basis for Priority Review ^260262258.
• FDA explicitly did not grant Priority Review, stating the product did not meet the criteria for unmet need or significant improvement ^260258262.

What was counted / how this conclusion was reached

• I reviewed the extracted Priority Review rationales and “significant improvement” language across the listed products and checked whether the same documents also:
  • explicitly described a prior injectable dosage form/route and a new oral dosage form/route, and
  • explicitly tied convenience (avoidance of injections/infusions, at-home administration, reduced burden, adherence) to the Priority Review significant-improvement justification.
• Several products had Priority Review plus oral dosage forms, and several had convenience language, but none contained the explicit injectable → oral switch being used as the significant improvement basis for Priority Review in the provided excerpts.

Implications for your research question

• Within this dataset slice, FDA’s Priority Review rationales that explicitly use “significant improvement” tend to emphasize effectiveness/safety/unmet need rather than explicitly crediting route-of-administration convenience—even when convenience is clearly relevant.
• Where convenience is explicitly mentioned as part of Priority Review reasoning, it may be framed as compliance/convenience improvements without necessarily being tied to an injectable → oral conversion (e.g., ATryn) ³⁶⁰.

Suggested next steps to find true injectable → oral Priority Review examples

• For candidates you suspect involve route conversion (e.g., oncology supportive care, antivirals, rare disease enzyme replacement alternatives), the most likely “smoking gun” documents are:
  • the Priority Review designation memo / request memo (often a short internal memo),
  • the Cross-Discipline Team Leader Review section that states the basis for Priority Review,
  • or the filing communication that sometimes summarizes the “significant improvement” rationale.
• If you want, provide a shortlist of drugs you believe had an injectable predecessor and later an oral formulation (or tell me the therapeutic area), and I can target the specific Priority Review memos/sections most likely to contain the explicit injectable → oral + convenience language you’re looking for (the current excerpts often don’t include those memos even when Priority Review is recorded elsewhere, e.g., cases like Zithromax where the sponsor argument is present but the grant status is not in the excerpt set) ⁶⁸²²⁹⁴.