Monthly summary of drug label changes December 2013

Monthly summary of drug label changes December 2013

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections

BW - Boxed Warning

C - Contraindications

W - Warnings

P - Precautions

AR - Adverse Reactions

PPI - Patient Package Insert

MG - Medication Guide

PCI - Patient Counseling Information


Drug Name

Iclusig (ponatinib) tablets

Tysabri (natalizumab) Injection

Hemabate (carboprost tromethamine) Sterile Solution Injection

Tikosyn (dofetilide) Capsules  

Avastin (bevacizumab)

Benlysta (belimumab)

Canasa (mesalamine) Rectal Suppository

Concerta (methylphenidate HCl) Extended-Release Tablets 

Daytrana (methylphenidate transdermal system) 

Focalin (dexmethylphenidate) tablets and Focalin XR (Dexmethylphenidate Hydrochloride) extended-release tablets

Drug Name

Metadate CD (methylphenidate HCl) Extended-Release Capsules

Methylin (methylphenidate) Oral Solution and Chewable Tablets

Plavix (clopidogrel bisulfate) Tablets

Quillivant XR (methylphenidate) extended-release oral suspension 

Ranexa (ranolazine) extended-release Tablets

Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Sustained-Release Tablets, and Ritalin LA Extended-Release Capsules 

Taxotere (docetaxel) Injection Concentrate

Yervoy (ipilimumab)

Brilinta (ticagrelor) Tablets

Pristiq (desvenlafaxine) Extended-Release Tablets

Drug Name

Tafinlar (dabrafenib) Capsules

Viibryd (vilazodone hydrochloride) tablets 

Adderall XR (mixed amphetamine salts) capsules

Amyvid (Florbetapir F 18 Injection)

Caverject Impulse Dual Chamber System (alprostadil for injection) 

Desoxyn (methamphetamine hydrochloride) tablets 

Dexedrine (dextroamphetamine sulfate) Spansule sustained release capsules

Lamictal (lamotrigine) tablets, chewable dispersible tablets

Lamictal ODT (lamotrigine) orally disintegrating tablets

Lamictal XR (lamotrigine) extended-release tablets

Drug Name

Lialda (mesalamine) Delayed-Release Tablets

Metastron (Strontium-89 Chloride) Injection

MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution)

Pentasa (mesalamine) Controlled-Release Capsules

Pradaxa (dabigatran etexilate mesylate) Capsules

Protonix (pantoprazole sodium) for Delayed-Release Suspension, and Delayed-Release Oral Tablets

Protonix I.V. (pantoprazole sodium) for Injection

Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules

Somavert (pegvisomant) injection

Vyvanse (lisdexamfetamine dimesylate) capsules

Drug Name

Zofran (ondansetron hydrochloride) Tablets, Oral Solution, Injection

Zofran ODT (ondansetron) Orally Disintegrating Tablets

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