Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

LUPRON DEPOT (NDA-020011)

(LEUPROLIDE ACETATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/10/2025 (SUPPL-47)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.3 Severe Cutaneous Adverse Reactions

Severe cutaneous adverse reactions (SCARs) have been reported in patients receiving GnRH agonists, including LUPRON DEPOT. These reactions include Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions (6.2)].

Monitor patients for the signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy. Advise patients of the signs and symptoms of SCARs.

If a SCAR is suspected, discontinue LUPRON DEPOT 3.75 mg. Consult with a healthcare provider with expertise in the diagnosis and management of SCARs. If a diagnosis of SCAR is confirmed, permanently discontinue LUPRON DEPOT 3.75 mg.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described elsewhere in the labeling:

Loss of Bone Mineral Density [see Warnings and Precautions (5.1)]
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3)]
Hypersensitivity Reactions [see Warnings and Precautions (5.4)]
Initial Flare of Symptoms with Management of Endometriosis [see Warnings and Precautions (5.5)]
Convulsions [see Warnings and Precautions (5.6)]
Clinical Depression [see Warnings and Precautions (5.7)]

6.2 Postmarketing Experience:

Additions and/or revisions underlined:

. . .

During postmarketing surveillance which includes other dosage forms and other populations, the following adverse reactions were reported:

Skin and Subcutaneous Tissue: rash, urticaria, photosensitivity, erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and acute generalized exanthematous pustulosis (AGEP)

. . .

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Severe Cutaneous Adverse Reactions

Inform patients that severe cutaneous adverse reactions (SCARs) may occur during treatment with LUPRON DEPOT 3.75 mg. Advise patients to discontinue LUPRON DEPOT 3.75 mg and immediately contact their healthcare provider if they experience signs or symptoms of SCARs [see Warnings and Precautions (5.3)].

. . .

09/10/2025 (SUPPL-48)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience:

Additions and/or revisions underlined:

. . .

During postmarketing surveillance which includes other dosage forms and other populations, the following adverse reactions were reported:

. . .

General disorders and administration site conditions: Injection site reactions including induration, abscess, and necrosis

. . .

02/12/2021 (SUPPL-42)

Approved Drug Label (PDF)

Other

(Physicians Labeling Rule (PLR) and Pregnancy and Lactation Labeling Rule (PLLR) conversion; please refer to label)