What is the FDA application number for this submission?

FDA application number ANDA217060, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is BRAVNETSA?

BRAVNETSA is formulated as: SOLUTION.

BRAVNETSA (LANTHEUS MEDICAL): FDA ORIG Approval, Not disclosed in the FDA record.

Key facts

Sponsor	LANTHEUS MEDICAL
Brand name	BRAVNETSA
Generic name	unspecified
Dosage form	SOLUTION
Application number	ANDA217060
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

The short version: LANTHEUS MEDICAL received anda approval for BRAVNETSA (unspecified) on 2026-09-21. Application number ANDA217060, submission type ORIG (submission 1). Dosage form: SOLUTION. 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 LANTHEUS MEDICAL as the sponsor of BRAVNETSA, with the generic name recorded as unspecified and dosage form SOLUTION. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. This specific application is submission type ORIG (submission number 1) under application number ANDA217060, with a submission status date of 20260921. 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.

Regulatory context

This application was reviewed under FDA's ORIG submission pathway. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. 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.

LANTHEUS MEDICAL’s FDA history

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

Frequently asked questions

What is the FDA application number for this submission?: FDA application number ANDA217060, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is BRAVNETSA?: BRAVNETSA is formulated as: SOLUTION.
What did FDA approve?: FDA's record shows anda approval for BRAVNETSA (unspecified), dosage form SOLUTION, sponsored by LANTHEUS MEDICAL, under application number ANDA217060. 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.

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Full FDA history for LANTHEUS MEDICAL

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). BRAVNETSA (LANTHEUS MEDICAL): FDA ORIG Approval, Not disclosed in the FDA record.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/lantheus-medical-anda217060-2026-09-21

MLA

"BRAVNETSA (LANTHEUS MEDICAL): FDA ORIG Approval, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/lantheus-medical-anda217060-2026-09-21.

Chicago

Argus HQ Research. "BRAVNETSA (LANTHEUS MEDICAL): FDA ORIG Approval, Not disclosed in the FDA record.." Digital Empire Holdings LLC. Accessed September 30, 2026. https://argushq.ai/approval/lantheus-medical-anda217060-2026-09-21.

BibTeX

@misc{argushq_argushq_ai_approval_lantheus_medical_anda217060_2026_09_21_2026,
  title = {BRAVNETSA (LANTHEUS MEDICAL): FDA ORIG Approval, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/lantheus-medical-anda217060-2026-09-21},
  note = {Accessed: September 30, 2026}
}

Source: FDA.gov — Approvals ↗