On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional. This document is provided in portable document format (PDF). These highlights do not include all the information needed to use EPIPEN ® and EPIPEN Jr ® safely and effectively. … Data sources include IBM Watson Micromedex (updated 11 Oct 2021), Cerner Multum™ (updated 1 … Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older ().At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with … IDHIFA ® (enasidenib) tablets, for oral use Initial U.S. Approval: 2017 . 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Drug Addiction Treatment Act 2.2 Important Dosage and Administration Information 2.3 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose The information in this Fact Sheet supersedes the information on the vial and carton labels. Refer to full prescribing information for specific dosing regimens. For assistance, please send an e-mail to: ocod@fda.hhs.gov • See the Full Prescribing Information for administration instructions. See full prescribing information for STRATTERA. Drugs.com reformats the style of these monographs, but the content is a duplicate of FDA-approved labeling. Revised: 11/2021 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 … HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROZAC safely and effectively. Full Prescribing Information . Data sources include IBM Watson Micromedex (updated 11 Oct 2021), Cerner Multum™ (updated 1 Dec 2021), … Revised: 10/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 … FULL PRESCRIBING INFORMATION 1. … Of the … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 5.11 Immunosuppression 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity … See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. In order to view PDF documents, you must have Adobe Reader software installed on your computer. FULL PRESCRIBING INFORMATION: CONTENTS* * Sections or subsections omitted from the full prescribing information are not listed. Revised: 4/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions 2.2 Dosing Information 2.3 Missed Dose 2.4 Preparation of Oral Solution by Pharmacists 3 DOSAGE FORMS AND STRENGTHS This professional information presents product monographs approved by the US Food and Drug Administration (FDA) and compiled by drug manufacturers. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . See full prescribing information for FORTEO. Please see full Prescribing Information for … 17 PATIENT COUNSELING INFORMATION * FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TEPEZZA is indicated for the treatment of Thyroid Eye Disease. See full prescribing information for KYPROLIS. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HUMIRA safely and effectively. Revised: 8/2021 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND … HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEURONTINsafely and effectively. Revised: 12/2018 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 … See full prescribing information for VRAYLAR. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TYRVAYA (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. If you do not have Adobe Reader, download it from the Adobe website . See full prescribing information for EPIPEN and EPIPEN Jr. EPIPEN ® … See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for COSELA. During storage, minimize exposure to room light. Prescribing Information. Find Drug Information on MedlinePlus. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 8DOSAGE AND ADMINISTRATION 3 8.1DOSAGE FORMS AND STRENGTHS 4 8.2CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 8.4 5.1 Immune Reconstitution … IMFINZI is indicated for the treatment of adult patients with unresectable Stage III See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Refer to full prescribing information for specific dosing regimens. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Easy-to-use resource from NIH with information about side effects, dosage, special precautions, and more for prescription and OTC drugs Revised: 7/2021 . Learn more about the prescribing of biosimilar and interchangeable products below. See full prescribing information … FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Non-Small Cell Lung Cancer. Valacyclovir Tablets, USP Initial U.S. Approval: 1995 Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. See 17 for PATIENT COUNSELING INFORMATION and FDA - approved patient labeling. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FERRIPROX Tablets safely and effectively. (See 21 CFR part 207.) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IDHIFA safely and effectively. DailyMed Announcements. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. WARNING: RISK OF SERIOUS INFECTIONS See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for valacyclovir hydrochloride tablets, USP. See full prescribing information for … *Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for … See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling . … See full prescribing information for … Data sources include IBM Watson Micromedex (updated 11 Oct 2021), Cerner Multum™ (updated 1 Dec 2021), … HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VRAYLAR safely and effectively. Posted: September 13, 2021. DESCOVY® (emtricitabine and tenofovir … See full prescribing information for IDHIFA. Revised: 10/2020 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Idiopathic Pulmonary Fibrosis 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype 1.3 Systemic Sclerosis-Associated Interstitial Lung Disease See full prescribing information … See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Approved Uses for Testosterone Therapy Are Limited. The FDA has approved various forms of testosterone therapy for men who have low levels of testosterone caused by medical conditions where the testicles fail to produce the hormone, including genetic problems and the side effects of chemotherapy. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CYMBALTA safely and effectively. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. ACTEMRA ® (tocilizumab) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2010 . Revised: 07/2020 . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEURONTINsafely and effectively. BLEPHAMIDE ® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile Full Prescribing Information. 1 Indications and Usage . 2.1 Prevention of Pregnancy 2.2 Switching from other Methods of Contraception . FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ... 2.5 Handling Information XATMEP is a cytotoxic drug. Revised: 08/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions 2.2 Recommended Dosage 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS To provide information regarding the effects of in utero exposure to LYRICA, physicians are advised to recommend that pregnant patients taking LYRICA enroll in the North American … Follow applicable special handling and disposal procedures.1 3 … Full Prescribing Information: Contents . Individuals using assistive technology may not be able to fully access the information contained in this file. In AMA style, the elements of a citation for a package insert are as follows (note that you may wish to include a trademark symbol if appropriate for the drug name). Revised: 7/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Treatment of Invasive Aspergillosis 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections 1.3 Treatment of Oropharyngeal Candidiasis Including HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use COSELA safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STRATTERA safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RINVOQ safely and effectively. Revised: 10/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . IMFINZI ® (durvalumab) injection, for intravenous use 2. Boxed Warning . DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. PRESCRIBING INFORMATION . If a dose is See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088. MARLBOROUGH, Mass., October 05, 2021--GE Healthcare Receives FDA Approval for Change in Contraindications in Prescribing Information for Optison Refer to the prescribing information for pertuzumab, administered in combination … See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for valacyclovir hydrochloride tablets, USP. See full prescribing information for DESCOVY. INDICATIONS AND USAGE 1.1 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies (14.1)]. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OPDIVO safely and effectively. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. COSELA Interstitial Lung Disease(trilaciclib) for injection, for intravenous use Initial U.S. Approval: CDK4/6 inhibitors should be. See full prescribing information for … Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.
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