What dosage form is ONSWIK?

ONSWIK is formulated as: INJECTABLE.

ELI LILLY AND CO — FDA ORIG Approval for ONSWIK (Not disclosed in the FDA record.)

Key facts

Sponsor	ELI LILLY AND CO
Brand name	ONSWIK
Generic name	unspecified
Dosage form	INJECTABLE
Application number	BLA761408
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

The short version: ELI LILLY AND CO received bla approval for ONSWIK (unspecified) on 2026-09-23. Application number BLA761408, submission type ORIG (submission 1). Dosage form: INJECTABLE. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

Regulatory context

This application was reviewed under FDA's ORIG submission pathway. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

What was approved

FDA's record shows ELI LILLY AND CO as the sponsor of ONSWIK, with the generic name recorded as unspecified and dosage form INJECTABLE. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. This specific application is submission type ORIG (submission number 1) under application number BLA761408, with a submission status date of 20260923. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

ELI LILLY AND CO’s FDA history

Argus HQ has recorded 1 total FDA action tied to ELI LILLY AND CO: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

What dosage form is ONSWIK?: ONSWIK is formulated as: INJECTABLE.
What did FDA approve?: FDA's record shows bla approval for ONSWIK (unspecified), dosage form INJECTABLE, sponsored by ELI LILLY AND CO, under application number BLA761408. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.
What does the submission type mean?: A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing.
Is this product available now?: FDA's record lists a submission status date of 20260923. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

Track this company's next FDA filing before it moves the stock.

Free weekly briefing on approvals, warning letters, and inspections.

Full FDA history for ELI LILLY AND CO

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). ELI LILLY AND CO — FDA ORIG Approval for ONSWIK (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/eli-lilly-and-bla761408-2026-09-23

MLA

"ELI LILLY AND CO — FDA ORIG Approval for ONSWIK (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/eli-lilly-and-bla761408-2026-09-23.

Chicago

Argus HQ Research. "ELI LILLY AND CO — FDA ORIG Approval for ONSWIK (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed September 30, 2026. https://argushq.ai/approval/eli-lilly-and-bla761408-2026-09-23.

BibTeX

@misc{argushq_argushq_ai_approval_eli_lilly_and_bla761408_2026_09_23_2026,
  title = {ELI LILLY AND CO — FDA ORIG Approval for ONSWIK (Not disclosed in the FDA record.)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/eli-lilly-and-bla761408-2026-09-23},
  note = {Accessed: September 30, 2026}
}

Source: FDA.gov — Approvals ↗