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.

AUVELITY (NDA-215430)

(BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE)

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

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04/30/2026 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Dizziness

Additions and/or revisions underlined:

AUVELITY may cause dizziness [see Adverse Reactions (6.1)]. In controlled studies of AUVELITY in depression, 14% of patients receiving AUVELITY and 6% of patients on placebo experienced dizziness. In a short-term controlled study of AUVELITY in agitation associated with dementia due to Alzheimer’s disease, 9% of patients receiving AUVELITY and 3% of patients on placebo experienced dizziness. Take precautions to reduce the risk of falls, particularly for patients with motor impairment a?ecting gait or those with a history of falls. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that AUVELITY therapy does not a?ect them adversely.

5.10 Hyponatremia

Newly added subsection:

Hyponatremia has occurred as a result of treatment with AUVELITY. One case with serum sodium of 115 mmol/L was reported in a subject treated with AUVELITY in a premarketing clinical study. Geriatric patients may be at greater risk of developing hyponatremia. Hyponatremia may be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Concomitant use of Auvelity with a serotonergic antidepressant may increase the risk of hyponatremia. Also, patients taking diuretics or who are otherwise volume-depleted can be at greater risk. Discontinue AUVELITY in patients with symptomatic hyponatremia and institute appropriate medical intervention. Signs and symptoms of hyponatremia include headache, di?culty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. More severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. [see Use in Speci?c Populations (Section 8.5)]

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hyponatremia [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

…

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

AUVELITY:

Feeling abnormal, tinnitus, and tremor.

…

Nervous System: Abnormal electroencephalogram (EEG), aggression, agitation, akinesia, aphasia, coma, completed suicide, delirium, delusions, depression, dysarthria, euphoria, extrapyramidal syndrome (dyskinesia, dystonia, hypokinesia, parkinsonism), hallucinations, homicidal ideation, hostility, increased libido, manic reaction, neuralgia, neuropathy, panic, paranoid ideation, psychosis, restlessness, suicide ideation, suicide attempt, unmasking tardive dyskinesia , and tremor.

…

Special Senses: Deafness, increased intraocular pressure, mydriasis, and tinnitus

8 Use in Specific Populations

8.5 Geriatric Use

Newly added information:

There were 720 patients 65 years of age and older in the clinical studies of AUVELITY for agitation associated with dementia due to Alzheimer’s disease [see Clinical Studies (14.2)]. Of the total number of AUVELITY-treated patients in these studies, 368 were 65 to less than 75 years of age, while 352 were 75 years of age and over. No overall di?erences in safety or e?ectiveness were observed between these subjects and younger subjects and other reported clinical experience has not identi?ed di?erences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

AUVELITY has been associated with clinically signi?cant hyponatremia in geriatric patients, who may be at greater risk for this adverse event [see Warnings and Precautions (5.10)].

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

PATIENT COUNSELING INFORMATION

Newly added information:

Hyponatremia

Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking AUVELITY [see Warnings and Precautions (5.10)].

MEDICATION GUIDE

Extensive changes; please refer to label for complete information

04/30/2026 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.7 Dizziness

Additions and/or revisions underlined:

5.10 Hyponatremia

Newly added subsection:

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hyponatremia [see Warnings and Precautions (5.10)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

…

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

AUVELITY:

Feeling abnormal, tinnitus, and tremor.

…

Special Senses: Deafness, increased intraocular pressure, mydriasis, and tinnitus.

8 Use in Specific Populations

8.5 Geriatric Use

Newly added information:

AUVELITY has been associated with clinically signi?cant hyponatremia in geriatric patients, who may be at greater risk for this adverse event [see Warnings and Precautions (5.10)].

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

PATIENT COUNSELING INFORMATION

Newly added information:

Hyponatremia

MEDICATION GUIDE

Extensive changes; please refer to label for complete information

11/05/2025 (SUPPL-16)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

05/07/2024 (SUPPL-8)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Cardiovascular: Complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe), phlebitis, pulmonary embolism, and Brugada pattern/syndrome.

…

Skin and subcutaneous tissue disorders: Alopecia, angioedema, exfoliative dermatitis, hirsutism, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

…