BLA number
125265
FDA Purple Book product · 351(a) biologic
Rotarix
Rotavirus Vaccine, Live, Oral
Rotarix, BLA 125265, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 3 exact FDA presentation rows, and no exact reference-product relationship is asserted. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(a)BLA 125265 3 presentationsDiscLicensed GlaxoSmithKline Biologicals
Approved
Nov 04, 2022
License type
351(a)
Marketing
Disc
Listed patents
0
Rotarix (Rotavirus Vaccine, Live, Oral) is GlaxoSmithKline Biologicals's FDA-licensed 351(a) biologic under BLA 125265, approved in 2022. No 351(k) product in the loaded Purple Book family data explicitly references Rotarix; that bounded result is not a claim about future reference-product eligibility.
Sourced from the FDA Purple Book · verified Jul 02, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(a) biologic
Applicant
GlaxoSmithKline Biologicals
Applicant is not automatically the physical manufacturer.
Presentations
3
Exact FDA presentation rows under this BLA.
Approval
Nov 04, 2022
Reference product
Not stated
Rotarix is an FDA-licensed 351(a) biologic.
No 351(k) product in the loaded Purple Book family data explicitly references Rotarix.
Substitution boundary
The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Nov 04, 2022
3 yr 9 mo ago
Today
Strengths & presentations
3 FDA presentation rows · BLA 125265
Strength
1ML
Dosage form
For Suspension
Route
Oral
Presentation
Single-Dose Vial
Center
CBER
License number
1617
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Strength
106.0CCID50
Dosage form
Suspension
Route
Oral
Presentation
Tube
Center
CBER
License number
1617
Product number
002
Submission type
Supplement
Supplement number
645
Change type
Not listed
Strength
106.0CCID50
Dosage form
Suspension
Route
Oral
Presentation
Oral Applicator
Center
CBER
License number
1617
Product number
003
Submission type
Supplement
Supplement number
645
Change type
Not listed
Exact presentation matrix
One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 1ML | For Suspension | Oral | Single-Dose Vial | Licensed | Disc |
| 002 | 106.0CCID50 | Suspension | Oral | Tube | Licensed | Disc |
| 003 | 106.0CCID50 | Suspension | Oral | Oral Applicator | Licensed | Rx |
Exact-source evidence coverage
Labeling & approval review
Current product label
Candidate awaiting exact-BLA match
FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.
Inspect FDA label candidateFDA approval evidence
Not applicable to 351(a)
A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
The current record does not expose a reference-product name or an exact linked 351(k) family for Rotarix.
No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.
Published patents
BPCIA patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Practical characteristics and limits
Source-bounded interpretation
Presentation coverage
3 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Oral and For Suspension and Suspension; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
GlaxoSmithKline Biologicals is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.
Regulatory comparison
Rotarix is an FDA-licensed 351(a) biologic. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.
Source provenance
FDA Purple Book data
Source kind · Advanced Search
Checked Jul 02, 2026- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
What this record does not establish
- Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
- The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
- Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
- A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
- Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.
Change history
Record versions
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Rotarix: frequently asked questions
Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.
Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
