FDA-approved Medication Guides 2019



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FDA-approved Medication Guides 2019

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Jeuveau – FDA

www.accessdata.fda.gov

Initial U.S. Approval: 2019 … INFORMATION and Medication Guide. ….. Advise
the patient to read the FDA-approved patient labeling (Medication Guide).

Aptensio XR – FDA

www.accessdata.fda.gov

Jun 14, 2019 … Information, Patient Package Insert, Medication Guide, and … acknowledge
receipt of your major amendment dated March 14, 2019, which …… Advise
patients to read the FDA-approved patient labeling (Medication Guide).

Label – FDA

www.accessdata.fda.gov

Please refer to your Supplemental New Drug Applications (sNDA) dated June 28,
2018, received … Instructions for Use, and Medication Guide), with the addition of
any labeling changes in …. Revised: 04/2019. 1 …… Advise the patient to read the
FDA-approved patient labeling (Medication Guide and Instructions for Use).

Label (PDF) – FDA

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Lactation: Advise not to breastfeed (8.2). See 17 for PATIENT COUNSELING
INFORMATION and Medication Guide. Revised: 07/2019. FULL PRESCRIBING …

label – FDA

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RUZURGI and drugs that lower seizure threshold may lead to an increased risk
of seizures. (7.1) … Medication Guide. Revised: 5/2019. FULL PRESCRIBING …

Desoxyn – FDA

www.accessdata.fda.gov

hours with about one-third as intact drug and the remainder as metabolites. ….
patients, their families, and their caregivers to read the Medication Guide and …

Label (PDF) – FDA

www.accessdata.fda.gov

2/2019. Indications and Usage. 2/2019. Warnings and Precautions.
Cardiovascular Death … Concomitant administration of ULORIC with XO
substrate drugs, …… Advise the patient to read the FDA-approved patient labeling
(Medication Guide).

colchicine – FDA

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Jan 7, 2019 … Guide. Revised: 1/2019. FULL PRESCRIBING INFORMATION: CONTENTS ….. to
read the FDA-approved patient labeling (Medication Guide).

HIGHLIGHTS OF PRESCRIBING … – Ironshore Pharmaceuticals

www.accessdata.fda.gov

Items 1 – 13 … See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 04/2019. Reference ID: 4433836 …… Advise the patient to read the FDA
-approved patient labeling (Medication Guide). Controlled Substance …

Tremfya – FDA

www.accessdata.fda.gov

See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 01/2019. 8 USE IN SPECIFIC ….. Advise the patient and/or caregiver to
read the FDA-approved patient labeling (Medication Guide and Instructions for
Use) …

Label (PDF) – FDA

www.accessdata.fda.gov

See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 03/2019. Reference ID: 4410921 …… See FDA-approved patient
labeling (Medication Guide and Instructions for Use). Risk of Serious Infections.
Reference …

Levaquin – FDA

www.accessdata.fda.gov

5/2019. Dissection (5.9). •. Warnings and Precautions,– Blood Glucose
Disturbances …. See 17 for PATIENT COUNSELING INFORMATION and
Medication …… Advise the patient to read the FDA-approved patient labeling (
Medication Guide).

CORLANOR® (ivabradine) Label – FDA

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Dosage and Administration (2.2). 04/2019. • Contraindications (4). 04/2019 …
See 17 for PATIENT COUNSELING INFORMATION and Medication …… patient to
read the FDA-approved patient labeling [see Medication Guide and Instructions
for.

Zelnorm™ (tegaserod) – FDA

www.accessdata.fda.gov

Mar 29, 2019 … Corresponding revisions were made to the Medication Guide. … We note that
your March 15, 2019 submission includes structured product …

Avoid Food and Drug Interactions – FDA

www.fda.gov

guide to alert you to possible “food-drug interactions” and to … In this guide, a
food-drug interaction is a change in how a …… FDA-approved drug labeling
written.

The Food and Drug Administration (FDA) approves a drug for …

www.fda.gov

Medication Guides convey risk infor- mation that is specific to particular drugs
and drug classes, and they contain FDA-approved information that can help …

Guidance for Industry – FDA

www.fda.gov

June 2019 … https://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/ …… support for each claim (e.g.,
specific page and lines of the FDA-approved full … Medication Guide with
annotations cross-referenced to the proposed …

Medication Guide for Nonsteroidal Anti-inflammatory Drugs … – FDA

www.fda.gov

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs). What is the
most important information I should know about medicines called Nonsteroidal …