Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

AIRDUO RESPICLICK (NDA-208799)

(FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)

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

Download Data

Expand all

07/09/2021 (SUPPL-21)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Avoid Excessive Use of AIRDUO RESPICLICK and Avoid Use with Other Long-Acting Beta2-Agonists

(Section title revised)

5.4 Oropharyngeal Candidiasis

(Section title revised)

5.5 Immunosuppression and Risk of Infections

(Section title revised)

5.6 Transferring Patients from Systemic Corticosteroid Therapy

(Newly added subsection headings)

HPA Suppression/Adrenal Insufficiency

Unmasking of Allergic Conditions Previously Suppressed by Systemic Corticosteroids

Corticosteroid Withdrawal Symptoms

6 Adverse Reactions

(Additions and/or revisions underlined)

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

Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1)]

Oropharyngeal candidiasis [see Warnings and Precautions (5.4)]
Immunosuppression and risk of infections [see Warnings and Precautions (5.5)]
Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7)]
Cardiovascular and central nervous system effects [see Warmings and Precautions (5.11)]

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of AIRDUO RESPICLICK have been established for the treatment of asthma in pediatric patients aged 12 years and older whose asthma (1) is inadequately controlled on a long term asthma control medication or (2) warrants initiation of treatment with both an ICS and a LABA.

Use of AIRDUO RESPICLICK in pediatric patients aged 12 to 17 years for this indication is supported by evidence from two adequate and well-controlled trials in pediatric patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2) [see Clinical Studies (14)]. In these trials, 58 adolescents received AIRDUO RESPICLICK one inhalation twice daily.

The safety and effectiveness of AIRDUO RESPICLICK have not been established in pediatric patients younger than 12 years of age for the treatment of asthma. Effectiveness was not demonstrated in one adequate and well-controlled study conducted in 211 patients aged 4 to 11 years with persistent asthma on a stable asthma regimen who were treated with AIRDUO RESPICLICK 55 mcg/14 mcg one inhalation twice daily.

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

Patient Information

(Extensive changes; please refer to label)

02/21/2020 (SUPPL-11)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

(additions underlined)

The safety and effectiveness of AIRDUO RESPICLICK in the treatment of asthma in pediatric patients aged 12 years and older whose asthma (1) is inadequately controlled on a long term asthma control medication or (2) warrants initiation of treatment with both an ICS and a LABA has been established. Use of AIRDUO RESPICLICK for this indication was supported by evidence from two adequate and well-controlled trials in pediatric patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2). In these trials, 58 adolescents received AIRDUO RESPICLICK one inhalation twice daily.

…

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

PATIENT COUNSELING INFORMATION

(additions underlined)

…

Dose Counter

Instruct patients that AIRDUO RESPICLICK has a dose counter that displays the number of actuations (inhalations) left in the inhaler. When the patient receives a new inhaler, the number 60 will be displayed. The dose counter will count down each time the mouthpiece is opened and closed. When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist or healthcare provider for a refill of their medication.

When the dose counter reaches 0, the patient should stop using the inhaler, and dispose of it in accordance with state and local regulations.

…

03/02/2018 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Eye: Cataracts, blurred vision, and central serous chorioretinopathy.

12/20/2017 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death

(Extensive changes; please refer to labeling)

6 Adverse Reactions

(Additions and/or revisions are underlined)

Use of LABA may result in the following:

Serious asthma-related events – hospitalizations, intubations, death
Cardiovascular and central nervous system effects

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Patients should be given the following information: Serious Asthma Events

Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization and asthma-related death. Available data show that when ICS and LABA are used together, such as with AIRDUO, there is not a significant increase in the risk of these events.