Boxed warning

Results: 212



#Item
101Pharmacology / Pyridines / Thiazolidinediones / Food and Drug Administration / Drug safety / Rosiglitazone / New Drug Application / Boxed warning / Pioglitazone / Pharmaceutical sciences / Pharmaceutical industry / Medicine

NDA[removed]SAFETY LABELING CHANGE, REMS, AND PMR NOTIFICATION

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Source URL: www.fda.gov

Language: English
102Organic chemistry / Pharmacology / Stimulants / Pfizer / Pyrazines / Varenicline / Bupropion / Boxed warning / Nicotine / Chemistry / Smoking cessation / Nicotinic agonists

Chantix Pediatric Safety and Use Review

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Source URL: www.fda.gov

Language: English
103Pharmacology / Health / Medicine / Tacrolimus / Pimecrolimus / Atopic dermatitis / Boxed warning / Atopy / Calcineurin / Immunosuppressants / Macrolides / Type 1 hypersensitivity

Topical Calcineurin Inhibitors Pediatric Safety Update: Regulatory Background Amy Sakulich Woitach, D.O., M.S. Medical Officer Division of Dermatology and Dental Products

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Source URL: www.fda.gov

Language: English
104Gadolinium / Nephrogenic systemic fibrosis / Magnetic resonance imaging / Boxed warning / Food and Drug Administration / Gadobenic acid / Gadopentetic acid / Gadodiamide / Chemistry / Matter / Medicine

Pediatric Focused Safety Review: MultiHance

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Source URL: www.fda.gov

Language: English
105Clinical research / Medicine / Patient safety / Food and Drug Administration / Therapeutics / United States Public Health Service / Medical prescription / Boxed warning / Pharmaceutical sciences / Clinical pharmacology / Pharmacology

Microsoft Word - 2nd Memo Referring to 2-26&7-09 RCAC+DSARM mtg.doc

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Source URL: www.fda.gov

Language: English
106Pharmacology / Tacrolimus / Health / Medicine / Pimecrolimus / Atopic dermatitis / Boxed warning / Atopy / Calcineurin / Immunosuppressants / Macrolides / Type 1 hypersensitivity

Topical Calcineurin Inhibitors Pediatric Safety Update: Regulatory Background Amy Sakulich Woitach, D.O., M.S. Medical Officer Division of Dermatology and Dental Products

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Source URL: www.fda.gov

Language: English
107Medicine / Matter / Medical terms / Adverse Event Reporting System / Norfloxacin / Gadodiamide / Boxed warning / Adverse effect / Gadolinium / Chemistry / Piperazines / Food and Drug Administration

Department of Health and Human Services Public Health Service Food and Drug Administration

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Source URL: www.fda.gov

Language: English
108Nootropics / Organic chemistry / Piperidines / Stimulants / Childhood psychiatric disorders / Methylphenidate / Attention deficit hyperactivity disorder / Atomoxetine / Boxed warning / Chemistry / Attention-deficit hyperactivity disorder / Pharmacology

Pediatric Focused Safety Review: Focalin® and Focalin XR® (dexmethylphenidate hydrochloride)

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Source URL: www.fda.gov

Language: English
109Food and Drug Administration / Clinical pharmacology / Pharmaceuticals policy / Drugs / Pharmaceutical industry / Boxed warning / Medical prescription / Prescription medication / Over-the-counter drug / Pharmaceutical sciences / Pharmacology / Medicine

FDA Risk Communication Advisory Committee

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Source URL: www.fda.gov

Language: English
110Androgens / Neuroendocrinology / Testosterone / Pharmacology / Boxed warning / Hypogonadism / Pharmacovigilance / Endocrine system / Medicine / Health

1 AndroGel® (testosterone gel) 1% CIII NDA[removed]Pediatric Advisory Committee June 23, 2009

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Source URL: www.fda.gov

Language: English
UPDATE