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.

ZEMBRACE SYMTOUCH (NDA-208223)

(SUMATRIPTAN SUCCINATE)

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

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06/10/2019 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

Additions and/or revisions underlined:

5.9 Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients receiving sumatriptan.

6 Adverse Reactions

6.1 Clinical Trials Experience

Newly added heading underlined:

Adverse Reactions in Placebo-Controlled Trials with Sumatriptan Injection

Migraine Headache: Table 1 lists adverse reactions …

Addition of the following:

Adverse Reactions in a Study with ZEMBRACE SymTouch

The most common adverse reactions in a placebo-controlled trial with ZEMBRACE SymTouch were injection site reactions (including injection site bruising, erythema, hemorrhage, induration, irritation, pain, paresthesia, pruritis, swelling, and urticaria), occurring in 30% of ZEMBRACE SymTouch-treated patients compared to 13% of placebo-treated patients. Adverse reactions with ZEMRACE SymTouch are expected to be similar to those observed with sumatriptan injection.

8 Use in Specific Populations

PLLR conversion; please refer to label for complete information.

8.1 Pregnancy

8.2 Lactation

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

PATIENT COUNSELING INFORMATION

‘Hypersensitivity’ replaces ‘Anaphylactic’

Additions and/or revisions underlined:

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant.

Lactation

…

PATIENT INFORMATION

What should I tell my healthcare provider before taking ZEMBRACE SymTouch?

Additions and/or revisions underlined:

are pregnant or plan to become pregnant. It is not known if ZEMBRACE SymTouch can harm your unborn baby.
are breastfeeding or plan to breastfeed. ZEMBRACE SymTouch passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider …

03/20/2017 (SUPPL-3)

Approved Drug Label (PDF)

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

Patient Information

(Additions and/or revisions are underlined)

How should I take ZEMBRACE SymTouch?

You may use a second dose of ZEMBRACE SymTouch after the first dose of ZEMBRACE SymTouch OR after one dose of another sumatriptan medication separated by at least 1 hour, but not sooner, if your headache comes back or you only get some relief after your first injection.
Do not take more than a total of 12 mg of ZEMBRACE SymTouch in a 24-hour period. Talk to your doctor about how many ZEMBRACE SymTouch you can take in a 24 hour period if you take another form of sumatriptan medication in between ZEMBRACE SymTouch.