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.

DYANAVEL XR 15 (NDA-210526)

(AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE)

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

Download Data

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09/23/2025 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Long-Term Suppression of Growth in Pediatric Patients

Additions and/or revisions underlined:

DYANAVEL XR is not approved for use and is not recommended in pediatric patients below 6 years of age [see Use in Specific Populations (8.4)].

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of DYANAVEL XR have not been established in pediatric patients below the age of 6 years.

In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

…

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

MEDICATION GUIDE

Additions and/or revisions underlined:

…

What is DYANAVEL XR?

DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.

DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

DYANAVEL XR is not recommended for use in children under 6 years of age with ADHD.

…

10/13/2023 (SUPPL-8)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or revisions underlined:

WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].

5 Warnings and Precautions

5.1 Abuse, Misuse, and Addiction

Additions and/or revisions underlined:

DYANAVEL XR has a high potential for abuse and misuse. The use of DYANAVEL XR exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. DYANAVEL XR can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection.

Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store DYANAVEL XR in a safe place, preferably locked, and instruct patients to not give DYANAVEL XR to anyone else. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.8 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

New subsection added:

CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].

Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or

Tourette’s syndrome. Regularly monitor DYANAVEL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1),

…

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.8)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Central Nervous System: restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication), motor and verbal tics

…

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Abuse, Misuse, and Addiction

Educate patients and their families about the risks of abuse, misuse, and addiction of DYANAVEL XR, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store DYANAVEL XR in a safe place, preferably locked, and instruct patients to not give DYANAVEL XR to anyone else.

…

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with DYANAVEL XR. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.8)].

…

MEDICATION GUIDE

Medication Guide has undergone extensive changes; please refer to label.

02/25/2022 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Long-Term Suppression of Growth

Additions underlined

…

Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted [see Use in Specific Populations (8.4)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions underlined

…

Gastrointestinal: unpleasant taste, constipation, intestinal ischemia, and other gastrointestinal disturbances

…

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined

…

Risk Summary

… No effects on morphological development were observed in embryo-fetal development studies with oral administration of amphetamine to rats and rabbits during organogenesis at doses that are approximately 3 and 16 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day (as base equivalents) on a mg/m2 basis, given to adults. However, long-term neurochemical and behavioral effects have been reported in published animal developmental studies using clinically relevant doses of amphetamine [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

…

Data

Animal Data

… These doses are approximately 3 and 16 times, respectively, the MRHD of 20 mg/day (as base equivalents) on a mg/m2 basis, given to adults. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 12 times the MRHD) given to adults on a mg/m2 basis or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

…

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

PATIENT COUNSELING INFORMATION

Additions underlined

…

Dosage and Administration Instructions

…

DYANAVEL XR extended-release tablets

o Tablets may be chewed or swallowed whole.

…