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.

ARMONAIR RESPICLICK (NDA-208798)

(FLUTICASONE PROPIONATE)

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

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04/08/2022 (SUPPL-13)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ArmonAir Digihaler has been evaluated from adequate and well-controlled studies of fluticasone propionate inhalation powder [ARMONAIR RESPICLICK, hereafter referred to as fluticasone propionate multidose dry powder inhaler (MDPI)].

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

PATIENT COUNSELING INFORMATION

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

PATIENT INFORMATION

What is ARMONAIR DIGHALER?

Newly added information:

ARMONAIR DIGIHALER does not need to be connected to the App in order for you to take your medicine. The electronic module does not control or interfere with delivery of the medicine through the inhaler.

How should I use ARMONAIR DIGIHALER?

Read the step-by-step instructions for using ARMONAIR DIGIHALER at the end of this Patient Information leaflet.

For detailed instructions on how to set up the App go to www.ARMONAIRDIGIHALER.com or call Teva Pharmaceuticals at 1-888-603-0788.
Connection to the App, having your Bluetooth turned on, or being near your smartphone is not required for your ARMONAIR DIGIHALER to work and for you to get your medicine.
The electronic module does not control or interfere with delivery of the medicine through the inhaler.

ARMONAIR DIGIHALER is for oral inhalation use only.

Other

‘Digihaler’ replaces ‘Respiclick’ throughout label

07/09/2021 (SUPPL-8)

Approved Drug Label (PDF)

6 Adverse Reactions

(Newly added information)

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

Oropharyngeal candidiasis [see Warnings and Precautions (5.1)]

Clinical Trials Experience

(Addition of studies in pediatric patients aged 4 to 11 years; see label for complete information)

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of ARMONAIR RESPICLICK in the maintenance treatment of asthma as prophylactic therapy in pediatric patients 4 years of age and older have been established.

Use of ARMONAIR RESPICLICK for this indication in adolescents ages 12 to 17 years is supported by evidence from two adequate and well-controlled trials in adult and adolescent patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2) [see Clinical Studies (14.2)]. In these trials, 50 adolescents received ARMONAIR RESPICLICK one inhalation twice daily.

Use of ARMONAIR RESPICLICK for this indication in pediatric patients aged 4 to 11 years is supported by evidence from one adequate and well-controlled trial of ARMONAIR RESPICLICK (Trial 3) [see Clinical Studies (14.2)]. In this trial, 419 pediatric patients received ARMONAIR RESPICLICK 30 mcg or 55mcg one inhalation twice daily.

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

Patient Information

(Additions and/or revisions underlined)

ARMONAIR RESPICLICK comes in 4 different strengths. Your healthcare provider prescribed the

strength that is right for you or your child.

• Use ARMONDAIR RESPICLICK 1 inhalation 2 times each day (about 12 hours apart) at the same

time every day.

Common side effects of ARMONAIR RESPICLICK in people ages 4 to 11 years old include:

• infections in the ear, nose and throat

These are not all the possible side effects with ARMONAIR RESPICLICK. Call your doctor for medical advice about side effects.

• Keep the green cap on the inhaler closed during storage.

• Keep your ARMONAIR RESPICLICK inhaler clean and dry at all times.

09/18/2020 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

(Additions underlined)

…

Immunosuppression and Risk of Infections [see Warnings and Precautions (5.3)]

…

8 Use in Specific Populations

8.4 Pediatric Use

(Additions underlined)

The safety and effectiveness of ARMONAIR RESPICLICK in the maintenance treatment of asthma as prophylactic therapy in pediatric patients 12 years of age and older has been established. Use of ARMONAIR 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) [see Clinical Studies (14)]. In these trials, 50 adolescents received ARMONAIR 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 the ARMONAIR RESPICLICK inhaler 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. The dose counter window displays the number of actuations (inhalations) left in the inhaler in units of two (e.g., 60, 58, 56, etc.). 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 it should be disposed of in accordance with state and local regulations.

…

PATIENT INFORMATION

(Additions underlined)

…

How should I use ARMONAIR RESPICLICK?

…

Use ARMONAIR RESPICLICK exactly as your healthcare provider tells you to use it. Do not use ARMONAIR RESPICLICK more often than prescribed.

Use ARMONDAIR RESPICLICK 2 times a day (about 12 hours apart) at the same time everyday

…

How should I store ARMONAIR RESPICLICK?

…

Store ARMONAIR RESPICLICK in a dry place. Avoid exposure to extreme heat, cold, or humidity.
…

03/02/2018 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

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