Tuesday, November 4, 2008

September 2008 posting includes 36 drug products with safety labeling changes to the following

The September 2008 posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2008/sep08_quickview.htm

The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2008/sep08.htm

In September 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Aceon (perindopril erbumine) Tablets
Proair HFA (albuterol sulfate) Inhalation Aerosol
EpiPen (epinephrine) Auto-Injector 0.3 mg & EpiPen JR (epinephrine) Auto-Injector 0.15 mg
Erbitux (cetuximab) Solution for Intravenous Use
Exubera (insulin human [rDNA origin]) Inhalation Powder
Gleevec (imatinib mesylate) Tablets
Heparin Sodium Injection, USP [Preservative Free]
Heparin Sodium Injection, USP [Preserved with Parabens]
Nasacort AQ (triamcinolone acetonide) Nasal Spray
Noroxin (norfloxacin) Tablets
Photofrin (porfimer sodium) Injection
Reyataz (atazanavir sulfate) Capsules
Rituxan (rituximab) Injection for Intravenous Use
Tarceva (erlotinib) Tablets
Uroxatral (alfuzosin HCl extended-release tablets)

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