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.

OGSIVEO (NDA-217677)

(NIROGACESTAT HYDROBROMIDE)

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

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08/20/2026 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

Newly added subsection:

5.6 Hypersensitivity Reactions

Hypersensitivity reactions, including severe hypersensitivity reactions, have been reported with postmarketing use of OGSIVEO. Monitor patients for signs and symptoms of hypersensitivity during treatment with OGSIVEO and manage as clinically indicated. Interrupt dosing or permanently discontinue OGSIVEO depending on the severity [see Dosage and Administration (2.2)].

6 Adverse Reactions

Additions and/or revisions underlined:

The following serious adverse reactions are described elsewhere in the labeling:

. . .

Hypersensitivity Reactions [see Warnings and Precautions (5.6)]

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Hypersensitivity

Advise patients that hypersensitivity reactions, including potentially severe reactions, may occur during treatment with OGSIVEO and to immediately report any signs and symptoms to their healthcare provider [see Dosage and Administration (2.2), Warnings and Precautions (5.6)].

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

What are the possible side effects of OGSIVEO? OGSIVEO can cause serious side effects, including:

. . .

Serious allergic reactions. OGSIVEO can cause allergic reactions that can be severe. Tell your healthcare provider right away if you develop any signs or symptoms of a severe allergic reaction during treatment with OGSIVEO, including:

skin rash
wheezing or trouble breathing
itching
swelling of the face, eyes, lips, tongue or throat
hives
dizziness or lightheadedness
chest pain
fever
fast heart rate
muscle or joint pain

Your healthcare provider will monitor you for signs or symptoms of a severe allergic reaction during treatment with OGSIVEO and may temporarily or completely stop treatment with OGSIVEO if you develop any signs or symptoms of a severe allergic reaction.

. . .

07/17/2026 (SUPPL-8)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Clinically relevant adverse reactions occurring in < 15% of patients receiving OGSIVEO in DeFi included non-melanoma skin cancers, epistaxis, hidradenitis suppurativa, folliculitis, influenza-like illness, renal tubular disorder, photopsia, vitreous floaters, and dry eye.

. . .

03/10/2026 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Clinically relevant adverse reactions occurring in less than 15% of patients receiving OGSIVEO in DeFi included non-melanoma skin cancers, epistaxis, hidradenitis suppurativa, folliculitis, influenza-like illness, and renal tubular disorder.

. . .

8 Use in Specific Populations

8.3 Females and Males of Reproductive Potential

Additions and/or revisions underlined:

. . .

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose. OGSIVEO can affect ovarian function and the development of the ovarian follicle and therefore may reduce the effectiveness of hormonal contraceptives. Addition of a barrier method is recommended for females using hormonal contraceptives.

. . .

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Addition of a barrier method is recommended for females using hormonal contraceptives.

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

Before taking OGSIVEO, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems.
are pregnant or plan to become pregnant. OGSIVEO can harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with OGSIVEO.
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment with OGSIVEO.
Use effective birth control (contraception) during treatment with OGSIVEO and for 1 week after the last dose. If you use a birth control method that contains hormones (for example, birth control pills, injections, or transdermal system patches), an additional barrier method of contraception (for example, diaphragm or condom) is recommended. Birth control methods that contain hormones may not work as well during treatment with OGSIVEO. Talk to your healthcare provider about birth control methods that may be right for you.

. . .