sábado, 13 de junio de 2015

FDA MedWatch - May 2015 Safety Labeling Changes includes 43 products with revisions to Prescribing Information

Safety Information > May 2015

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The MedWatch May 2015 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections:BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections:
Androderm (testosterone) Transdermal System 
AndroGel (testosterone) Gel
Avastin (bevacizumab) Solution for Intravenous Infusion 
Aveed (testosterone undecanoate) Injection
Axiron (testosterone) Topical Solution
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablet 
Delatestryl (testosterone enanthate) Injection 
Edurant (rilpivirine) Tablet 
Erivedge (vismodegib) Capsules
Fluvirin (influenza Vaccine) 
Fortesta (testosterone) Gel
Gilenya (fingolimod) Capsules
Intron A (interferon alfa-2b), Recombinant for Injection
Lamictal (lamotrigine) Chewable Dispersible Tablets
Lamictal (lamotrigine) Tablets
Lamictal ODT (lamotrigine) Orally Disintegrating Tablets 
Natesto (testosterone) Nasal Gel
Nicorette (nicotine polacrilex) Lozenges 
PegIntron (peginterferon alfa-2b), Injection for Subcutaneous Use
Perjeta (pertuzumab) Injection, for Intravenous Use 
Prezista (darunavir) Tablet and Oral Suspension
Provera (medroxyprogesterone acetate) Tablets 
Rebetol (ribavirin) Capsules and Oral Solution 
Sirturo (bedaquiline) Tablets 
Striant (testosterone buccal system) Mucoadhesive
Sylatron (peginterferon alfa-2b) for Injection, for Subcutaneous Use 
Testim (testosterone) Gel
Testosterone Gel, for Topical Use
Trokendi XR (topiramate) Extended-release Capsules 
Tysabri (natalizumab) Injection, for Intravenous Use 
Vogelxo (testosterone) Gel 
VPRIV (velaglucerase alfa for injection)

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