FDA approves Sun Pharma's Vobrig, a leuprolide acetate injection
The new drug application for Vobrig, a subcutaneous leuprolide acetate solution, received FDA approval with a status date of August 26, 2026.
The FDA approved Sun Pharma's new drug application for Vobrig (NDA213225) as of August 26, 2026, according to agency records. The submission was classified as a Type 5 application, covering a new formulation or new manufacturer.1
Vobrig is formulated as a subcutaneous solution containing leuprolide acetate at a strength of 28MG/2.8ML, equivalent to 10MG/ML.1 The review was designated as standard priority rather than expedited.1
FDA records list the submission status as "AP," indicating approval, with a submission status date of 2026-08-26.1 Supporting application documents were dated slightly after the approval status date. The approval letter is dated August 28, 2026, while the product label and an accompanying medication guide are both dated September 1, 2026.1
The FDA's public database identifies Sun Pharm as the sponsor of the application. No additional details on indication, dosing regimen, or clinical trial data supporting the approval were included in the available FDA records.
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