Halozyme Therapeutics Inc (HALO)

[Skeetz99]

THROMBOEMBOLISM - PEG20

CELGENES Cancer drug REVLIMID had similar THROMBOEMBOLISM events and the FDA addressed the problem by mandating a Label warning (currently, REVLIMID is a very successfull drug that has been launched and selling for years). With HALO's PEG20 have a similar problem; and with the initial Survival looking for encouraging; I expect the FDA will move PEG20 forward mandate a similar Label warning as well.

Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL New Drug Application
Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use REVLIMID® safely and effectively. See full prescribing information for REVLIMID.

REVLIMID [lenalidomide] capsules, for oral use

Initial U.S. Approval: 2005
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS THROMBOEMBOLISM Less

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