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.

SEEBRI (NDA-207923)

(GLYCOPYRROLATE)

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

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07/30/2021 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Hypersensitivity Reactions, including Anaphylaxis

Addition to title underlined

Immediate hypersensitivity reactions have been reported after administration of SEEBRI NEOHALER. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria, or skin rash, SEEBRI NEOHALER should be discontinued immediately andalternative therapy instituted. SEEBRI NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

6 Adverse Reactions

Additions underlined

…

Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions (5.3)]

…

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion

Risk Summary

There are no adequate and well-controlled studies with SEEBRI NEOHALER in pregnant women. Women should be advised to contact their physician if they become pregnant while taking SEEBRI NEOHALER.

In animal reproduction studies, there were no evidence of fetal harm or structural abnormalities in Wistar rats or New Zealand White rabbits at inhaled doses approximately 1,400 and 530 times, respectively, the maximum recommended human dose (MRHD of 31.2 mcg) on an area under the curve (AUC) basis (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Clinical Considerations

Labor or Delivery

The potential effect of SEEBRI NEOHALER on labor and delivery is unknown. SEEBRI NEOHALER should be used during labor and delivery only if the potential benefit to the patient justifies the potential risk to the fetus.

Data

Animal Data

In embryo-fetal development studies, pregnant Wistar rats received daily inhalation doses of glycopyrrolate, during the period of organogenesis from gestation days 7 to 17, at exposures up to 1,400 times the MRHD (on an AUC basis with maternal inhaled doses up to 3.83 mg/kg) and pregnant New Zealand White rabbits received daily inhalation doses of glycopyrrolate, during the period of organogenesis from gestation days 7 to 19, at exposures up to 530 times the MRHD on an AUC basis with maternal inhaled doses up to 4.4 mg/kg). Glycopyrrolate produced no evidence of teratogenicity in Wistar rats or New Zealand White rabbits at exposures up to approximately 1,400 and 530 times, respectively the MRHD.

In a pre- and postnatal development study in pregnant Wistar rats, glycopyrrolate was administered subcutaneously daily throughout the periods of organogenesis and lactation from gestation day 6 through lactation day 23 at exposures up to 1,100 times the MRHD (on an AUC basis with maternal subcutaneous doses up to 1.88 mg/kg/day). Glycopyrrolate had no effects on physical, neurological, or reproductive development in rats following exposures up to approximately 1,100 times the MRHD.

8.2 Lactation

PLLR conversion

Risk Summary

There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. However, in a study of lactating rats, glycopyrrolate was present in the milk (see Data).

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SEEBRI NEOHALER and any potential adverse effects on the breastfed child from SEEBRI NEOHALER or from the underlying maternal condition.

Data

Animal Data

Glycopyrrolate and its metabolites were detected in the milk of lactating rats following a single intravenous injection of 4 mg/kg of radiolabeled glycopyrrolate.

01/19/2017 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

…These adverse reactions are: angioedema, paradoxical bronchospasm and dysphonia.