FDA Medication Guides 2019



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FDA Medication Guides 2019

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Aptensio XR – FDA

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Jun 14, 2019 … Information, Patient Package Insert, Medication Guide, and … We acknowledge
receipt of your major amendment dated March 14, 2019, which.

Approval (COR-BLAACTION-03) – FDA

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JEUVEAU may be potentiated (7). See 17 for PATIENT COUNSELING.
INFORMATION and Medication Guide. Revised: 02/2019. Reference ID:
4384428 …

HIGHLIGHTS OF PRESCRIBING INFORMATION These … – FDA

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2/2019. Indications and Usage. 2/2019. Warnings and Precautions …
Concomitant administration of ULORIC with XO substrate drugs, azathioprine or …

Reference ID: 4428998 – FDA

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Medication Guide. Revised: 5/2019. FULL PRESCRIBING INFORMATION:
CONTENTS*. 1 INDICATIONS AND USAGE. 2 DOSAGE AND ADMINISTRATION
.

Reference ID: 4457635 – 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 …

Reference ID: 4374201 – FDA

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surgery if halogenated anesthetics will be used (7). See 17 for PATIENT
COUNSELING INFORMATION and Medication. Guide. Revised: 1/2019.
Reference ID: …

NDA 020987/S-055 NDA 020988/S-061 NDA 022020/S-017 … – FDA

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Pregnancy: Based on animal data, may cause fetal harm. (8.1). See 17 for
PATIENT COUNSELING INFORMATION and. Medication Guide. Revised: 04/
2019. 1.

HIGHLIGHTS OF PRESCRIBING … – Ironshore Pharmaceuticals

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Items 1 – 13 … Pharmaceuticals Inc. at 1-877-938-4766 or FDA at 1-800-FDA-1088 or www.fda.
gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and
Medication. Guide. Revised: 04/2019. Reference ID: 4433836 …

HIGHLIGHTS OF PRESCRIBING INFORMATION These … – FDA

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See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 3/2019. FULL PRESCRIBING INFORMATION: CONTENTS*. WARNING
: …

• LEVAQUIN Tablets cannot be administered to pediatric … – FDA

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See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 6/2019. 5.8 Hepatotoxicity. 5.9 Risk of Aortic Aneurysm and Dissection.

Guidance for Industry – FDA

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Center for Biologics Evaluation and Research (CBER). July 2019. Drug Safety …..
The following changes to a Medication Guide that is an element of a REMS:c.

HIGHLIGHTS OF PRESCRIBING INFORMATION These … – FDA

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cimetidine, fluconazole, cyclosporine, rifampin, and caffeine. (7.1). See 17 for
PATIENT COUNSELING INFORMATION and Medication. Guide. Revised: 3/2019
.

Reference ID: 4409346 – FDA

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CYP3A4 inducers is not recommended (7.6). See 17 for PATIENT COUNSELING
INFORMATION and Medication. Guide. Revised: 3/2019. FULL PRESCRIBING …

CORLANOR® (ivabradine) Label – FDA

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See 17 for PATIENT COUNSELING INFORMATION and Medication. Guide.
Revised: 04/2019. FULL PRESCRIBING INFORMATION: CONTENTS*.

Avoid Food and Drug Interactions – FDA

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What you eat and drink can affect the way your medicines work. Use this guide to
alert you to possible “food-drug interactions” and to help you learn what.

HIGHLIGHTS OF PRESCRIBING INFORMATION These … – Pfizer

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Indications and Usage. 3/2019. INDICATIONS AND USAGE. • FLECTOR is a
nonsteroidal … 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/
medwatch. … See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.

A Prescriber's Guide to the New Medicare Part D Opioid – CMS.gov

www.cms.gov

Nov 1, 2018 … prescribe opioid medications to patients with a Medicare Part D prescription drug
benefit. … Administration (FDA)-approved labeling). Specific to prescription
opioids, beginning in January 2019, Medicare Part D plans will …

Reference ID: 4373796 – FDA

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Pregnancy: Based on animal data, may cause fetal harm (8.1). See 17 for
PATIENT COUNSELING INFORMATION and Medication. Guide. Revised: 1/2019
.