Fensolvi Kit

Treats central precocious puberty (CPP). NDA 213150, held by Tolmar. Leuprolide Acetate.

As of Nov 14, 2026, NDA 213150 (Fensolvi Kit), held by Tolmar, was first approved by FDA on May 1, 2020, with 5 approved supplements and 0 published complete response letters.

First approved: May 1, 2020
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 1, 2020	Original applicationNew indication · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fensolvi Kit45MG · powder;subcutaneous	Leuprolide Acetate	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 11Labeling · Standard review	Approved	Label Medication Guide Letter
May 5, 2025	Supplement 7Labeling · Standard review	Approved	Letter
Oct 17, 2024	Supplement 4Labeling · Standard review	Approved	Label Letter
Nov 25, 2022	Supplement 3Manufacturing · Standard review	Approved	Label Letter
Apr 22, 2022	Supplement 2Labeling · Standard review	Approved	Label Letter
May 1, 2020	Original applicationNew indication · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 213150
Drugs@FDA: Overview at FDA
Company: Tolmar, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters